A Preliminary Study on Shortening the Postoperative Immobilization Time after Femoral Artery Puncture in the Chinese Population

A Preliminary Study on Shortening the Postoperative Immobilization Time after Femoral Artery Puncture in the Chinese Population | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A Preliminary Study on Shortening the Postoperative Immobilization Time after Femoral Artery Puncture in the Chinese Population Feng Liu, Chunyan Tang, Shuqing Wang, Qiang Zou, Wenjun Li, Liang Zhu, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8288517/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective According to the Chinese "Clinical Practice Guidelines for Transarterial Chemoembolization of Liver Cancer" (Version 2021), the operative limb should be immobilized for 6–12 hours following femoral arterial puncture. In 2001, the American Heart Association and its Committee on Clinical Cardiology recommended immobilizing the surgical limb for 2–6 hours. Prolonged immobilization might create discomfort, defer treatment plans, and reduce bed utilization. It is worth investigating whether the Chinese population's postoperative immobilization period might be reduced. The purpose of this study was to determine the feasibility of shortening the postoperative immobilization time following femoral artery puncture. Methods Hemostasis, compression, bandaging, and immobility following femoral artery puncture are all linked to postoperative problems. We chose the best current hemostasis approach while keeping consistent compression and bandaging circumstances. Furthermore, we investigated the possibility of reducing postoperative immobilization time. To ensure adequate hemostasis at the puncture site, we used an in vitro hemostasis test to find a hemostatic patch with greater efficiency. On this basis, we investigated the prospect of shortening the immobilization period following femoral artery puncture. We enrolled 82 individuals who agreed to a 5F femoral artery puncture from six hospitals in China. Accoring to the Central Randomization principle, patients were randomly assigned to one of the two groups: early mobilization (immobilization time: 5 ~ 6 hours) or late mobilization (8 ~ 12 hours). The rates of complications, such as postoperative puncture site hemorrhage and subcutaneous hematoma, were compared between them. Results In the hemostasis effect test assay, the chitin hemostatic patch shows a better hemostatic effect than gauze and was thus chosen as the fixed condition for the hemostatic stages in subsequent investigations. The complication ratio after femoral artery puncture did not differ significantly between individuals randomly assigned to early or late mobilization (P = 0.999, 95% CI: -2.6%~11.8%). Early mobilization is safe for individuals undergoing 5F femoral artery puncture in included Chinese population. Conclusion Immobilization time shortening after femoral artery puncture in the Chinese population is potential which requires additional validation in a larger sample. This reduced immobilization time will serve to relieve patient discomfort, shorten the course of disease, and promote the development of outpatient interventional treatment. Femoral artery puncture Immobilization time Chitin Haemostasis TACE Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction Interventional technology, a minimally invasive diagnostic and treatment technology, is now widely used in the diagnosis and treatment of a variety of diseases, including primary hepatocellular carcinoma, coronary atherosclerotic heart disease, deep vein thrombosis of the lower limbs, pulmonary tuberculosis, gastrointestinal bleeding, and so on 1–4 . Interventional diagnosis and treatment approaches are classified into two types based on the access route used: vascular intervention and non-vascular intervention 5 , 6 . Vascular interventions often use the femoral or radial artery as access 7 , 8 . In comparison, radial artery puncture results in smaller wounds, easier compression to stop bleeding, and fewer limits on patient activities following operation. However, due to the radial artery's average lumen width of less than 3 mm, the access tube is tiny, prone to spasm and rupture, and frequently constricted during puncture 9 – 11 . The femoral artery has a greater diameter, a more fixed location, and a more prominent pulse; hence puncture success rates are frequently higher than those of the radial artery 12 , 13 . The femoral artery puncture is the most often used method in clinical vascular interventional diagnosis and treatment 14 . Puncture Site Bleeding is the most common vascular consequence following femoral artery puncture, which might present as seeping of blood, subcutaneous hematoma, pseudoaneurysm, arteriovenous fistula, etc 15 – 17 . About 5% to 10% of patients will experience minor bleeding or subcutaneous hematoma following surgery, and approximately 1.5% of patients will experience unmanageable severe bleeding and require blood transfusion or even surgery 18 . Manual compression hemostasis is the most traditional and commonly utilized method for hemostasis following femoral artery puncture 19 . The requirements for postoperative hemostasis in the clinical guidelines for femoral artery puncture vary across countries and regions due to differences in factors affecting vascular hemostasis, such as coagulation ability, muscle contractility, and arterial blood pressure 20 – 22 . In 2001, the American Heart Association and the American Heart Association Committee on Clinical Cardiology issued recommendations on postoperative hemostasis after femoral artery puncture, which recommended that the surgeon manually apply pressure to the puncture site for 10 to 20 minutes after femoral artery puncture and then have the patient immobilize the limb for 2 to 6 hours 23 . In the "Chinese Clinical Practice Guidelines for Transarterial Chemoembolization of Liver Cancer" published in China in 2021, it is recommended that surgeons manually press the femoral artery puncture site for at least 15 minutes after transarterial chemoembolization (transarterial chemoembolization,TACE) using the femoral artery approach and then use an elastic bandage for pressure dressing. After the operation, the patient needs to rest in bed and keep the lower limb on the puncture side immobilized for at least 6 to 12 hours. Prolonged immobilization can cause discomfort, delay treatment plans, and reduce bed utilization. Whether the postoperative immobilization time can be shortened is a question worth exploring. This study aimed to explore the feasibility of shortening the postoperative immobilization time after femoral artery puncture in Chinese population. Results Hemostasis, compression, bandaging, and immobilization after femoral artery puncture are all closely associated with postoperative complications. We selected the best currently available hemostasis strategy, while maintaining consistent compression and bandaging conditions. Furthermore, we explored the possibility of shortening the postoperative immobilization time. To ensure effective hemostasis at the puncture site, we firstly screened for a hemostatic patch with superior hemostatic efficacy by in vitro hemostasis test. On this basis, we explored the possibility of shortening the immobilization time after femoral artery puncture in clinical practice (Fig. 1 ). Hemostasis, compression, bandaging, and immobilization after femoral artery puncture are all closely associated with postoperative complications. We selected the best currently available hemostasis strategy, while maintaining consistent compression and bandaging conditions. Furthermore, we explored the possibility of shortening the postoperative immobilization time. To ensure effective hemostasis at the puncture site, we screened a hemostatic product with superior hemostatic efficacy by in vitro hemostasis test. Through a rat tail transection experiment, after 1–2 ml of blood was exuded from the wound, a 2 cm × 2 cm three-layer sterile gauze or a 0.5 cm × 0.5 cm chitosan hemostatic patch was applied to contact the blood and cover the wound (Fig. 2 A). The site was pressed for 2 minutes, and hemostatic effects were observed. If no anticoagulants were present in the rats' drinking water, no significant difference in hemostatic effect was found between the two hemostatic patches mainly composed of chitosan, and the hemostatic effect of both chitosan patches was significantly higher than that of sterile gauze (Fig. 2 C). After pretreating rats with dual antiplatelet drugs, no significant difference in hemostatic effect was observed between the two chitosan hemostatic dressings, and both were still significantly more effective than sterile gauze (Fig. 2 D). Therefore, it can be inferred that hemostatic dressings with chitosan as the main active ingredient have a better hemostatic effect compared to traditional sterile gauze, while there is no significant difference in hemostatic effect between the two chitosan dressings. These pieces of evidence indicate that Haemostatic dressings with kaolin are more effective at stopping bleeding than gauze. Since the two chitosan hemostatic products did not show differences in the rat tail amputation hemostasis experiment, we only selected chitosan hemostatic product A for subsequent experiments. A. Schematic diagram of rat tail hemostasis experiment. The experiment uses SPF-grade SD rats, which are pretreated with either antiplatelet drugs or an equal volume of pure water. After cutting off the tip of the rat's tail, hemostatic dressings are applied to stop the bleeding and construct the experimental model. The three hemostatic dressings used in this experiment are: sterile hemostatic gauze, chitosan hemostatic patch A, and chitosan hemostatic patch B. B. Schematic diagram of the main hemostatic mechanism of chitosan. The free amino groups of chitosan form positively charged groups, which, through interactions between positive and negative charges, adsorb negatively charged RBCs on the surface, causing them to aggregate into clusters and form a tight 'chitosan-RBC' complex. C. Comparison of hemostatic rates of three hemostatic dressings in a rat (pure water-fed) tail amputation hemostasis experiment with a pure water control group. D. Comparison of hemostatic rates of three hemostatic dressings in the rat (anticoagulant-fed) tail amputation bleeding experiment with pure water as the control group. Chitosan is a natural cationic polysaccharide rich in free amino groups, widely found in the shells of arthropods such as shrimp, crabs, and insects, in the cell membranes of algae, and in the cell walls of higher plants 24 , 25 . Chitosan possesses excellent hemostatic properties and good biocompatibility. Hemostatic dressings with chitosan as the main active ingredient have been used on battlefields to quickly control bleeding and have gradually expanded to civilian use in recent years. As a novel biological hemostatic material, research on the hemostatic mechanisms of chitosan has been extensively reported. Chitosan exhibits a complex, multifactorial synergistic hemostatic mechanism, including charge adsorption, platelet membrane receptor activation and coagulation factor release, and biological regulation 26 – 28 (Fig. 2 B). To further verify the hemostatic mechanism of chitosan hemostatic dressing A that we used, we made a glass trough and placed the hemostatic dressing at one end of the trough, analyzing the composition ratios of blood components at both ends. We defined the proximal end as the end of the rectangular glass trough closest to the hemostatic dressing, and the distal end as the end farthest from the hemostatic dressing. We measured the RBC, WBC, and PLT counts at both the proximal and distal ends of all samples (Fig. 3 A and 3 B). The results indicate that there are significant differences in the concentration distribution of RBCs (Fig. 3 C) and PLTs (Fig. 3 D) between the proximal and distal ends of Chitosan Hemostatic Patch A, suggesting that Chitosan Hemostatic Patch A can significantly induce the migration of RBCs and PLTs toward the proximal end in blood samples. In contrast, sterile hemostatic gauze shows a significant difference in PLT concentration but not in RBC concentration between the proximal and distal ends, indicating that sterile hemostatic gauze can only induce the migration of PLTs toward the proximal end(Fig. 3 E). Therefore, it can be concluded that Chitosan Hemostatic Patch A has a significant capacity to adsorb both RBCs and PLTs, whereas sterile hemostatic gauze mainly adsorbs PLTs. In addition, we observed that neither hemostatic dressing showed significant differences in WBC concentrations between the proximal and distal ends, suggesting that both have negligible adsorption capacity for WBCs. Blood is composed of plasma and three types of blood cells: RBCs, WBCs, and PLTs. Previous literature reports that chitosan mainly achieves rapid hemostasis by electrically attracting and aggregating RBCs locally 29 , 30 . In this study, we also observed that the RBC count at the proximal end of the Chitosan Hemostatic Patch A experimental group was lower than at the distal end, whereas the sterile hemostatic gauze showed no significant difference in RBC concentration between the proximal and distal ends(Fig. 3 G). This confirms that Chitosan Hemostatic Patch A has a far greater adsorption capacity for RBCs than sterile hemostatic gauze. Correspondingly, the total count of WBCs and PLTs at the proximal end of the Chitosan Hemostatic Patch A group was higher than at the distal end, and the proportion of non-red blood cells remaining in the glass trough at the proximal end was also higher than at the distal end(Fig. 3 C, 3 D, 3 E and 3 F), demonstrating that Chitosan Hemostatic Patch A primarily adsorbed RBCs in the blood. Compared with chitosan hemostatic patches, traditional sterile hemostatic gauze relies heavily on the body's inherent physiological hemostatic mechanisms. Therefore, when platelet (PLT) count is reduced or platelet function is abnormal, sterile hemostatic gauze often fails to achieve effective hemostasis. In clinical practice, patients with decreased PLT levels often face limitations when undergoing interventional procedures due to their poor coagulation function, suboptimal results from traditional manual compression hemostasis, and a higher risk of postoperative bleeding. The 2021 Chinese publication "Clinical Practice Guidelines for Transarterial Chemoembolization in Hepatocellular Carcinoma" clearly states that patients with a PLT count < 50×10 9 /L should first consider correcting the PLT deficiency before undergoing interventional procedures; if the patient has refractory PLT deficiency that cannot be corrected after treatment, interventional procedures are prohibited 31 – 33 . Chitosan hemostatic patch A does not rely entirely on the platelet-mediated hemostatic mechanism, allowing it to maintain certain hemostatic effects even in patients with impaired coagulation function. This feature is particularly significant for many patients with impaired coagulation due to infections, liver dysfunction, cancer, or myelosuppression caused by chemotherapy. A. Flowchart for preparing a blood cell migration experimental model. All glass wells were randomly assigned to the chitosan hemostatic patch experimental group and the sterile gauze control group. B. Schematic diagram of the preparation of the blood cell migration experimental model. Diluted fresh goat arterial blood is injected into a glass chamber, and at the proximal end of the glass chamber, a chitosan hemostatic patch A or sterile gauze is placed. After standing for 1 minute, blood samples are taken from the proximal and distal ends of the glass chamber to detect RBC, WBC, and PLT in the samples.C. Changes in RBC counts at proximal and distal sites under the influence of different hemostatic dressings. D. Changes in WBC counts at proximal and distal sites under the influence of different hemostatic dressings.E. Changes in PLT counts at proximal and distal sites under the influence of different hemostatic dressings. F. The proportions of different blood cell types at the proximal and distal sites under the influence of different hemostatic dressings. G. In vitro induced blood cell migration experiment: differences in blood cell distribution. To ensure effective hemostasis at the puncture site, we screened hemostatic dressings with superior hemostatic effects through in vitro hemostasis tests. Based on this, this study included 82 patients undergoing 5F femoral artery puncture from six domestic hospitals and according to the Central Randomization principle to randomly divide the enrolled patients into an early activity group and a late activity group (Fig. 4 A and 4 B). Among them, the early activity group included 41 patients, who had their limb immobilization removed and got out of bed 5–6 hours postoperatively; the late activity group included 40 patients, who had their limb immobilization removed and got out of bed 8–12 hours postoperatively (Fig. 4 B). Through post-femoral artery puncture hemostasis experiments, we compared the differences in postoperative complication rates between patients with different immobilization durations and evaluated the safety of postoperative immobilization for patients in the early and late activity groups. We also analyzed hemostasis-related factors such as patients’ preoperative RBC count, PLT count, and PT-INR, and explored the feasibility of using Chitosan Hemostatic Dressing A to shorten postoperative immobilization time for patients with certain coagulopathy. Statistical analysis (Fig. 5 ) of the baseline data of the included patients showed that there were no significant differences in demographic information such as gender, age, height, and weight between the two groups. In addition, we excluded factors that could affect hemostasis between different groups, such as diseases and medications, including hypertension, diabetes, thrombosis, atrial fibrillation, use of anticoagulants, bleeding, use of hemostatic drugs, tumors, and jaundice. The results showed that the clinical characteristics between the two groups were similar. Comparing hemostasis-related factors between the two groups of patients, the results showed no significant differences in preoperative RBC count, PLT count, or PT-INR. There were 11 patients whose baseline data were partially missing due to improper data storage, so they were not included in the final baseline characteristic comparison, but the results were included in the intention-to-treat analysis. A comparison of postoperative complication rates between patients with complete data and those with partially missing baseline data showed no statistically significant differences, indicating that the missing data were likely random and had limited impact on the overall results. Based on guideline recommendations and the results of preliminary exploratory pre-experiments, we plan to randomly divide all enrolled patients into two groups. In the early mobilization group (n = 41), patients' operative limb immobilization time post-surgery will be 5–6 hours, while in the late mobilization group (n = 40), immobilization time will be 8–12 hours. Both groups will undergo right lower limb femoral artery puncture using a 5F arterial sheath and will receive hemostasis with chitosan hemostatic patches A postoperatively. Adverse reactions will be observed and recorded until 48 hours after the end of limb immobilization. By comparing the incidence of postoperative complications between the two groups with different immobilization durations, we evaluated the safety of postoperative immobilization in the early mobilization group versus the late mobilization group, with particular focus on the safety of postoperative immobilization in the early mobilization group. Clinical trial results showed no significant difference in the incidence of postoperative complications between patients in the early mobilization group and those in the late mobilization group (P = 0.999, 95% CI: -2.6%-11.8%), suggesting that early mobilization (immobilization time 5–6 hours) is safe for domestic patients undergoing 5F femoral artery puncture. Among the enrolled patients, only one case of subcutaneous hematoma occurred in the early mobilization group, with an overall postoperative complication rate of 1.23%; in the early mobilization group, the complication rate was 2.44%, which is not significantly higher compared with the 1.6%-31.4% incidence of vascular-related postoperative complications reported in some recent domestic studies on femoral artery punctures 34 – 36 . Furthermore, none of the 81 enrolled patients exhibited other postoperative complications such as skin allergies, generalized pain, back stiffness or discomfort, urinary retention, deep vein thrombosis, infection, or vascular embolism, further demonstrating the safety of postoperative immobilization in the early mobilization group. Reducing immobilization time can help alleviate patient discomfort caused by immobilization, shorten hospital stay, and facilitate the implementation of outpatient interventional procedures. A. Sample Data Source Distribution Probability Chart. The enrolled patients come from 6 hospitals in China, accounting for 9%, 11%, 12%, 15%, 17%, and 36%, respectively. B. Flowchart of hemostasis after femoral artery puncture. This study included 81 patients aged ≥ 15 and < 90 years, of both sexes, with an expected survival of ≥ 4 weeks, suitable for right lower limb femoral artery puncture using a 5F arterial sheath, and with a total surgery duration not exceeding 3 hours. Patients with severe coagulation disorders (PLT count < 10×10 9 ), allergic diseases, or inability to control consciousness were excluded. Patients were randomized at the center into an early activity group (immobilization time of 5 ~ 6 hours) and a late activity group (immobilization time of 8 ~ 12 hours). a.Baseline data were missing for 11 patients, who were not included in the final comparison of baseline characteristics; b, Baseline data were missing for 3 patients, who were not included in the final comparison of baseline characteristics. A. Comparison of Postoperative Complication Rates in Patients Undergoing Hemostasis Experiments After Femoral Artery Puncture. B. Comparison of Hemostasis-Related Factors in Patients Undergoing Femoral Artery Puncture Hemostasis Experiment. C-F, Hemostasis-related factors in patients undergoing femoral artery puncture hemostasis experiments. A. Some enrolled patients had a preoperative RBC count below the normal reference range. B. Some enrolled patients had a preoperative PLT count below the normal reference range. C. Some enrolled patients had a preoperative PT-INR above the normal reference range, D. Some enrolled patients received ≥ 1000U of heparin during the procedure; a. Data were missing for 11 patients; b. Data were missing for 3 patients. Discussion This study is to provide experimental evidence for optimizing postoperative hemostasis time by tentatively investigating the viability of reducing the hemostasis time following femoral artery puncture. It is based on the status of post-femoral artery puncture hemostasis in Chinese patients. First, we examined popular hemostatic dressings on the market and chose a hemostatic patch with chitosan as the primary active ingredient as the research topic in order to guarantee successful hemostasis at the puncture site. A common cationic polysaccharide found in nature, chitosan has free amino groups 37 – 40 . Previous studies have shown that chitosan has a complex, multifactorial synergistic hemostatic mechanism and is a new type of biologically valuable hemostatic material 27 , 29 , 41 . To screen for dressings with excellent hemostatic effects, we severed the tails of healthy adult rats and used sterile gauze and two types of chitosan hemostatic patches for hemostasis respectively, comparing the differences in hemostatic effects among different dressings. The results showed that the hemostatic effect of chitosan patches was significantly better than that of traditional sterile gauze, so chitosan hemostatic patch A was used for subsequent experiments. Subsequently, we designed a series of experiments to verify the hemostatic mechanism of chitosan hemostatic patch A. Previous studies have shown that numerous amino groups exist on the molecular chain of chitosan, which can form positively charged groups under physiological pH, attracting RBCs on the negatively charged surfaces of cell membranes, forming a "chitosan-RBC" tight complex within seconds. This mechanism does not depend on the activation of platelets (PLT) or the coagulation pathway, so hemostatic dressings containing chitosan can still exert a certain hemostatic effect even under conditions of impaired coagulation function. We placed chitosan hemostatic patch A on one side of a glass trough injected with diluted fresh goat arterial blood. After standing for 1 minute, blood samples were collected from both the ends near and far from the patch, and by comparing the distribution differences of RBCs, WBCs, and PLTs between proximal and distal samples, we verified that chitosan hemostatic patch A has a significant role in adsorbing RBCs in blood samples. The evidence we provide suggests that for domestic patients undergoing 5F femoral artery puncture, early ambulation (with a compression time of 5–6 hours) is safe. Shortening the post-femoral artery puncture compression time is worth further confirmation in larger sample populations in the domestic setting. Meanwhile, we have some limitations. Firstly, in our clinical trial optimizing hemostasis time after femoral artery puncture, we only selected patients undergoing the most common procedure using a 5F arterial sheath for femoral artery puncture as the study population. We did not include larger sheath sizes, nor did we include other common interventional access points such as the radial artery. Therefore, at present, we can only recommend the use of Chitosan Hemostatic Pad A for hemostasis and a 6-hour limb immobilization protocol after femoral artery puncture with a 5F sheath.For a standard randomized controlled trial (RCT) aiming to demonstrate a reduction in immobilization time to 5 ~ 6 hours, our rigorous calculations indicate that a minimum of 1,038 patients would be required. Limited by time and cost, this study included a smaller sample size, which weakens statistical power. Although we have preliminarily shown that a 5 ~ 6-hour immobilization time is safe in domestic patients undergoing 5F femoral artery puncture, reducing post-femoral artery puncture immobilization time in the domestic population still needs to be confirmed in larger-scale studies. Shortening the immobilization time will help alleviate patient discomfort caused by the tourniquet, shorten hospital stays, and support the outpatient implementation of interventional procedures. Selection bias may be introduced because some patients' baseline data is lacking. It is impossible to totally rule out the possibility that the missing data could have an impact on the outcomes, even if the data may be absent at random. Future studies should pay attention to data management measures to minimize the risk of baseline data loss. Finally, the clinical trial lacks long-term follow-up data. Whether the use of Chitosan Hemostatic Pad A increases the risk of hypercoagulable states or thrombosis in the long term remains unclear and requires further investigation. Overall, Immobilization time shortening after femoral artery puncture in the Chinese population is potential which requires additional validation in a larger sample. This reduced immobilization time will serve to relieve patient discomfort, shorten the course of disease, and promote the development of outpatient interventional treatment. STAR METHODS Detailed methods are provided in the online version of this paper and include the following: METHOD DETAILS Rat tail transection hemostasis experiment A total of 46 SPF-grade SD rats were selected, all male, each weighing 250 ± 30 g, aged 8–10 weeks. Prior to the experiment, they were adaptively housed in a temperature- and humidity-controlled animal room for 7 days, with free access to food and water. The animal room temperature was 22 ± 1°C, and humidity was 50 ± 5%. Using a random grouping method, 46 independent random numbers were generated by the random number generator in SPSS statistical software (version 25.0). After arranging the random numbers in ascending order, the first 22 rats were assigned to the antiplatelet drug pre-treatment group, and the remaining 24 rats were assigned to the pure water control group. Within each group, rats were further allocated using a systematic sampling method. The 22 rats in the antiplatelet drug pre-treatment group were divided into the sterile hemostatic gauze pre-treatment group (n = 8), chitosan hemostatic patch A pre-treatment group (n = 6), and chitosan hemostatic patch B pre-treatment group (n = 8). The 24 rats in the pure water control group were divided into the sterile hemostatic gauze control group (n = 8), chitosan hemostatic patch A control group (n = 8), and chitosan hemostatic patch B control group (n = 8). Antiplatelet drug or pure water retreatment:(1) Take 100 mg of aspirin enteric-coated tablets and 75 mg of clopidogrel hydrogen sulfate tablets, place them in a 1000 ml beaker at room temperature, add 500 ml of purified water, and stir thoroughly with a glass rod until completely dissolved. Then, make up to 600 ml to obtain a dual antiplatelet drug suspension;(2) 24 hours before the experiment, add 200 ml of the dual antiplatelet drug suspension to the drinking bottles of the rats in the antiplatelet drug pretreatment group, while the pure water control group receives an equal volume of purified water. Both groups of rats are allowed to drink freely.1.2.3 Pre-experiment. Preparation (1) Fast the rats for 24 hours and water-deprive for 8 hours before the experiment;(2) Weigh and number each rat, and mark a positioning line for tail amputation approximately 2 cm from the tip of the tail with a medical marking pen. Then, transfer the rats to a room temperature environment and rest for at least 30 minutes;(3) Stack sterile hemostatic gauze in three layers and cut to a size of 2 cm × 2 cm for later use. Cut two types of chitosan hemostatic dressings into 0.5 cm × 0.5 cm pieces for later use.1.2.4 Establishment of Rat Tail Amputation Hemostasis Model(1) Hold the rat with its belly facing up and head slightly lower than the body;(2) According to the rat’s weight, use a 2 ml sterile syringe to draw 3 ml/kg of 10% chloral hydrate solution;(3) Perform intraperitoneal anesthesia in the lower left quadrant of the rat’s lower abdomen, avoiding the bladder and midline abdominal vessels. Insert the syringe needle at a 30° angle to the skin until it enters the abdominal cavity. Aspirate to confirm no blood or fluid reflux, then slowly inject the 10% chloral hydrate solution. After injection, gently press the needle puncture site to prevent leakage;(3) Observe for 10 minutes. Successful anesthesia is indicated by relaxed muscles and reduced pain response in the rat;(4) Place the anesthetized rat in a prone position on the surgical table, and disinfect the skin at the tail apex positioning line with a 75% medical alcohol cotton ball in a circular manner three times, each interval 30 seconds;(5) Clamp the tail above the positioning line with hemostatic forceps for 30 seconds, then quickly amputate vertically at the positioning line with a surgical knife;(6) After 1–2 ml of blood oozes from the tail wound, use the 2 cm × 2 cm three-layer sterile gauze or 0.5 cm × 0.5 cm chitosan hemostatic dressing to cover the wound and press for 2 minutes to stop bleeding without interruption. Alternatively, remove the dressing to observe hemostasis. Rats in the sterile gauze pretreatment and control groups use sterile gauze for hemostasis; rats in the chitosan dressing A pretreatment and control groups use chitosan dressing A; rats in the chitosan dressing B pretreatment and control groups use chitosan dressing B. The hemostatic effect was recorded and analyzed. Data were statistically analyzed using SPSS software (version 25.0). Categorical data were expressed as counts and percentages. The chi-square test or Fisher's exact test was used to compare whether there were statistically significant differences in the hemostatic effects of three different hemostatic dressings on rat tail amputation wounds between the antiplatelet pretreatment group and the pure water control group. All tests were two-sided, and P < 0.05 was considered statistically significant. Blood cell migration assay Collect 10 ml of fresh goat arterial blood within 1 hour and place it in a 200 ml beaker at room temperature. Dilute it with 0.9% saline at a 1:10 volume ratio and stir thoroughly with a glass rod for 10 seconds. Using a micropipette, take the diluted fresh blood and randomly assign it into groups. Six independent random numbers were generated using the random number generator in SPSS statistical software (version 25.0). After arranging the random numbers in ascending order, the first three of the six glass troughs containing the diluted fresh goat arterial blood were assigned to the chitosan hemostatic patch experimental group, and the remaining three were assigned to the sterile hemostatic gauze control group. The two ends of each rectangular glass trough, which are the farthest apart, were labeled as the proximal and distal ends, respectively. Cut chitosan hemostatic patch A and three-layer stacked sterile hemostatic gauze into 2 cm × 2 cm pieces. Place the cut chitosan hemostatic patch A at the proximal end of the glass trough in the experimental group, closely adhered to the glass, and place the three-layer stacked sterile hemostatic gauze at the proximal end of the glass trough in the control group, closely adhered to the glass. Let them sit for 1 minute. Then, using a 2 ml sterile syringe, collect 2 ml samples of the diluted fresh goat arterial blood from both the proximal and distal ends of each glass trough, as shown in Figs. 4 and 5 , to test the RBC, WBC, and PLT counts for all samples. Experimental Data Statistics and Analysis Data were statistically analyzed using SPSS software (version 25.0). Categorical data were expressed as counts and percentages. The chi-square test or Fisher's exact test was used to compare whether there were statistically significant differences in the hemostatic effects of three different hemostatic dressings on rat tail amputation wounds between the antiplatelet drug pretreatment group and the pure water control group. All tests were two-sided, and P < 0.05 was considered statistically significant. Clinical sample collection A total of 82 patients who underwent right lower limb femoral artery puncture with a 5F arterial sheath in six domestic hospitals from September 2022 to March 2025 were selected. According to the inclusion and exclusion criteria described below, 81 patients were ultimately included in the study. Inclusion Criteria:a. Patients aged ≥ 15 years and < 90 years, of any gender;b. Patients with an expected life expectancy of ≥ 4 weeks;c. Patients suitable for right lower limb femoral artery puncture using a 5F arterial sheath;d. Total surgery duration not exceeding 3 hours. Exclusion Criteria:a. Patients with severe coagulation disorders (PLT count < 10×10 9 ); b. Patients with allergic diseases;c. Patients unable to maintain self-awareness even with the assistance of family members. Declarations RESOURCE AVAILABILITY Lead contact Further information and requests for resources should be directed to and will be fulfilled by the lead contact, Jingjing Li ( [email protected] ). Materials availability This study did not generate new unique reagents. Data and code availability All data reported in this paper will be shared by the lead contact upon request. This article does not report the original code. Any additional information required to reanalyze the data reported in this article is available from the lead contact upon request. AUTHORCONTRIBUTIONS Jingjing Li and Feng designed the research; Qiang Zou, Guangyue Bai, Kang Liu, Guiqing Li, Yi Zheng, Liang Zhu, Wenjun Li, Shuqing Wang, Heng Zhang, Yuntao Wang, Chunyan Tang, Xueqin Wang and Xueqin Wu performed the experiments. Jingjing LI, Feng Liu and Yuntao Wang wrote and organized the manuscript; Jingjing Li, and Feng Liu revised the manuscript and reorganized the figures. DECLARATION OF INTERESTS The authors declare that they have no competing interests. Ethics approval and consent to participate The animal experiments involved in this study were all approved by the Ethics Committee of the Affiliated Hospital of Shandong Second Medical University. The clinical trials involved in this study were approved by the Medical Ethics Committee of the Second Medical University of Shandong Affiliated Hospital (NO. wyfy-2022-ky-249) and the National Medical Research Registration Information System (MR-37-24-028084). All patients provided verbal or written informed consent before enrollment. Consent for publication Written informed consent was obtained from all individual participants included in the study. The consent form explicitly stated that the participants' data (including any potentially identifying information such as images or case details) would be published in a scientific journal. ACKNOWLEDGMENTS In this work Jingjing Li and Feng Liu is supported by the National Natural Science Foundation of China (Grant No. 82104289), Shandong Provincial Health Commission(M-2022053), Science and Technology Innovation Plan from Weifang Medical University (041004), Yuandu Scholar Grant of Weifang City to LJJ, Weifang Science and Technology Bureau Plan Project (2021YX081), Science and technology project jointly established by the Science and Technology Department of the State Administration of Traditional Chinese Medicine (GZY-KJS-SD-2023-079), Shandong Provincial Medical Association Young Talent Promotion Project (2023_GJ_0039). Science and Technology Innovation Plan from Weifang Medical University (041011). We acknowledge Tricol Biomedical for supplying the chitosan patches (HemCon Patch® PRO ,1076). References Yao L et al (2025) Application of Nanotechnology in TACE Treatment of Liver Cancer. 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Aust Crit Care 36:915–923. 10.1016/j.aucc.2022.10.018 Darbha K et al (2025) Vascular access: Femoral, radial and large-bore alternative access. Prog Cardiovasc Dis 88:2–19. 10.1016/j.pcad.2024.12.009 Liu P et al (2015) Radial versus femoral artery access for percutaneous coronary angiography and intervention: a systematic review and meta-analysis of randomized controlled trials in Chinese population. Int J Clin Exp Med 8:17151–17166 Khan AA et al (2019) Safety and efficacy of radial versus femoral access for rotational Atherectomy: A systematic review and meta-analysis. Cardiovasc Revasc Med 20:241–247. 10.1016/j.carrev.2018.06.006 Ding W, Luo Y, Li W (2024) Advancements in Vascular Closure Devices for Effective Hemostasis in Femoral Artery Interventions. Med Sci Monit 30:e944884. 10.12659/MSM.944884 Noori VJ, Eldrup-Jorgensen J (2018) A systematic review of vascular closure devices for femoral artery puncture sites. 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J Am Coll Cardiol 37:2170–2214. 10.1016/s0735-1097(01)01346-8 Edo GI, Yousif E, Al-Mashhadani MH, Chitosan (2024) An overview of biological activities, derivatives, properties, and current advancements in biomedical applications. Carbohydr Res 542:109199. 10.1016/j.carres.2024.109199 Rafiq M et al (2024) Recent developments in the biomedical and anticancer applications of chitosan derivatives. Int J Biol Macromol 283:137601. 10.1016/j.ijbiomac.2024.137601 Wang YW et al (2019) Biological Effects of Chitosan-Based Dressing on Hemostasis Mechanism. Polym (Basel) 11. 10.3390/polym11111906 Fan P, Zeng Y, Zaldivar-Silva D, Aguero L, Wang S (2023) Chitosan-Based Hemostatic Hydrogels: The Concept, Mechanism, Application, and Prospects. Molecules 28. 10.3390/molecules28031473 Zhao J et al (2023) Chitosan-based hydrogel wound dressing: From mechanism to applications, a review. Int J Biol Macromol 244:125250. 10.1016/j.ijbiomac.2023.125250 Zhang S, Lei X, Lv Y, Wang L, Wang LN (2024) Recent advances of chitosan as a hemostatic material: Hemostatic mechanism, material design and prospective application. Carbohydr Polym 327:121673. 10.1016/j.carbpol.2023.121673 Wang Y et al (2021) Red blood cell-hitchhiking chitosan nanoparticles for prolonged blood circulation time of vitamin K(1). Int J Pharm 592:120084. 10.1016/j.ijpharm.2020.120084 Angiolillo DJ et al (2024) International Consensus Statement on Platelet Function and Genetic Testing in Percutaneous Coronary Intervention: 2024 Update. JACC Cardiovasc Interv 17:2639–2663. 10.1016/j.jcin.2024.08.027 Wang Q et al (2024) Machine learning-based model for predicting tumor recurrence after interventional therapy in HBV-related hepatocellular carcinoma patients with low preoperative platelet-albumin-bilirubin score. Front Immunol 15:1409443. 10.3389/fimmu.2024.1409443 Zong DW et al (2016) Influence of lactulose on interventional therapy for HCC patients with hepatocirrhosis and hypersplenism. Asian Pac J Trop Med 9:193–196. 10.1016/j.apjtm.2016.01.011 Grechenig P, Wittig U, di Vora T, Prager W, Hohenberger G (2023) Emergency approach to the femoral artery. Eur J Trauma Emerg Surg 49:1337–1341. 10.1007/s00068-022-02211-7 Xia J et al (2006) Study of severe and rare complications of transarterial chemoembolization (TACE) for liver cancer. Eur J Radiol 59:407–412. 10.1016/j.ejrad.2006.03.002 Liapi E, Georgiades CC, Hong K, Geschwind JF (2007) Transcatheter arterial chemoembolization: current technique and future promise. Tech Vasc Interv Radiol 10:2–11. 10.1053/j.tvir.2007.08.008 Jimenez-Gomez CP, Cecilia JA, Chitosan (2020) A Natural Biopolymer with a Wide and Varied Range of Applications. Molecules 25. 10.3390/molecules25173981 Wai SN et al (2022) Chitosan-Sodium Caseinate Composite Edible Film Incorporated with Probiotic Limosilactobacillus fermentum: Physical Properties, Viability, and Antibacterial Properties. Foods 11. 10.3390/foods11223583 De Gaetano F et al (2022) Chitosan/Cyclodextrin Nanospheres for Potential Nose-to-Brain Targeting of Idebenone. Pharmaceuticals (Basel) 15. 10.3390/ph15101206 Jafernik K et al (2023) Chitosan-Based Nanoparticles as Effective Drug Delivery Systems-A review. Molecules 28. 10.3390/molecules28041963 Guo Y et al (2023) Recent advances in the medical applications of hemostatic materials. Theranostics 13:161–196. 10.7150/thno.79639 Additional Declarations The authors declare no competing interests. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8288517","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":555875467,"identity":"0fd7f4ba-2725-4103-942a-ee38afef7c62","order_by":0,"name":"Feng Liu","email":"","orcid":"","institution":"Affiliated Hospital of Shandong Second Medical University, School of Clinical Medicine, Shandong Second Medical University, Weifang 261053, Shandong, 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15:37:28","extension":"html","order_by":16,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":130022,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/dd8117c9b2c482e1824f3c48.html"},{"id":97766536,"identity":"107c94e8-5958-4ccb-aee0-502fdc9fa975","added_by":"auto","created_at":"2025-12-09 07:16:31","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":96500,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSchematic diagram of this research design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHemostasis, compression, bandaging, and immobilization after femoral artery puncture are all closely associated with postoperative complications. We selected the best currently available hemostasis strategy, while maintaining consistent compression and bandaging conditions. Furthermore, we explored the possibility of shortening the postoperative immobilization time.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/cbe6f81a04501f64c7bccbd2.png"},{"id":97766539,"identity":"8a3908ef-ec8f-4616-9b76-527409db4a71","added_by":"auto","created_at":"2025-12-09 07:16:31","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":88376,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eScreening the best hemostatic dressings through rat tail hemostasis experiment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA. Schematic diagram of rat tail hemostasis experiment. The experiment uses SPF-grade SD rats, which are pretreated with either antiplatelet drugs or an equal volume of pure water. After cutting off the tip of the rat's tail, hemostatic dressings are applied to stop the bleeding and construct the experimental model. The three hemostatic dressings used in this experiment are: sterile hemostatic gauze, chitosan hemostatic patch A, and chitosan hemostatic patch B. B. Schematic diagram of the main hemostatic mechanism of chitosan. The free amino groups of chitosan form positively charged groups, which, through interactions between positive and negative charges, adsorb negatively charged RBCs on the surface, causing them to aggregate into clusters and form a tight 'chitosan-RBC' complex. C. Comparison of hemostatic rates of three hemostatic dressings in a rat (pure water-fed) tail amputation hemostasis experiment with a pure water control group. D. Comparison of hemostatic rates of three hemostatic dressings in the rat (anticoagulant-fed) tail amputation bleeding experiment with pure water as the control group.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/5fab77df24df3260b2fbf18a.png"},{"id":97766540,"identity":"8e797edd-3fb9-43a8-8ca8-9c4be04e336c","added_by":"auto","created_at":"2025-12-09 07:16:31","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":70598,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSchematic diagram of this research design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA. Flowchart for preparing a blood cell migration experimental model. All glass wells were randomly assigned to the chitosan hemostatic patch experimental group and the sterile gauze control group. B. Schematic diagram of the preparation of the blood cell migration experimental model. Diluted fresh goat arterial blood is injected into a glass chamber, and at the proximal end of the glass chamber, a chitosan hemostatic patch A or sterile gauze is placed. After standing for 1 minute, blood samples are taken from the proximal and distal ends of the glass chamber to detect RBC, WBC, and PLT in the samples.C. Changes in RBC counts at proximal and distal sites under the influence of different hemostatic dressings. D. Changes in WBC counts at proximal and distal sites under the influence of different hemostatic dressings.E. Changes in PLT counts at proximal and distal sites under the influence of different hemostatic dressings. F. The proportions of different blood cell types at the proximal and distal sites under the influence of different hemostatic dressings. G. In vitro induced blood cell migration experiment: differences in blood cell distribution.\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/29d2d7ed69016517fb16761f.png"},{"id":97896547,"identity":"d75607f2-70b7-4529-8090-21661316fba0","added_by":"auto","created_at":"2025-12-10 15:36:44","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":87123,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSchematic diagram of this research design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA. Sample Data Source Distribution Probability Chart. The enrolled patients come from 6 hospitals in China, accounting for 9%, 11%, 12%, 15%, 17%, and 36%, respectively. B. Flowchart of hemostasis after femoral artery puncture. This study included 81 patients aged ≥15 and \u0026lt;90 years, of both sexes, with an expected survival of ≥4 weeks, suitable for right lower limb femoral artery puncture using a 5F arterial sheath, and with a total surgery duration not exceeding 3 hours. Patients with severe coagulation disorders (PLT count \u0026lt;10×10\u003csup\u003e9\u003c/sup\u003e), allergic diseases, or inability to control consciousness were excluded. Patients were randomized at the center into an early activity group (immobilization time of 5~6 hours) and a late activity group (immobilization time of 8~12 hours).\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/ffe48465236cff3a5f979038.png"},{"id":97896719,"identity":"8f5c0147-4fe4-4db4-918c-d5c414754802","added_by":"auto","created_at":"2025-12-10 15:36:55","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":52690,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of general data of patients in the hemostasis experiment after femoral artery puncture.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea.Baseline data were missing for 11 patients, who were not included in the final comparison of baseline characteristics; b, Baseline data were missing for 3 patients, who were not included in the final comparison of baseline characteristics.6. TMEM199 regulate PD-L1 mRNA level.\u003c/p\u003e","description":"","filename":"floatimage5.png","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/a562ef1dbc8a40cf5f560064.png"},{"id":97766546,"identity":"ac456dd9-878d-45cb-85aa-5a2d800a5f21","added_by":"auto","created_at":"2025-12-09 07:16:31","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":81810,"visible":true,"origin":"","legend":"\u003cp\u003eSchematic diagram of this research design\u003c/p\u003e\n\u003cp\u003eA. Comparison of Postoperative Complication Rates in Patients Undergoing Hemostasis Experiments After Femoral Artery Puncture. B. Comparison of Hemostasis-Related Factors in Patients Undergoing Femoral Artery Puncture Hemostasis Experiment. C-F, Hemostasis-related factors in patients undergoing femoral artery puncture hemostasis experiments. A. Some enrolled patients had a preoperative RBC count below the normal reference range; B. Some enrolled patients had a preoperative PLT count below the normal reference range; C. Some enrolled patients had a preoperative PT-INR above the normal reference range, D. Some enrolled patients received ≥1000U of heparin during the procedure; a. Data were missing for 11 patients; b. Data were missing for 3 patients.\u003c/p\u003e","description":"","filename":"floatimage6.png","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/cfa877c7b6f0e5ecdc1cd8d0.png"},{"id":98421765,"identity":"8b34756b-b530-4411-9c3d-fcfbbeddc538","added_by":"auto","created_at":"2025-12-17 16:29:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1079536,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8288517/v1/0f6d8270-2328-4bc2-b8ef-e43ad3877401.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eA Preliminary Study on Shortening the Postoperative Immobilization Time after Femoral Artery Puncture in the Chinese Population\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eInterventional technology, a minimally invasive diagnostic and treatment technology, is now widely used in the diagnosis and treatment of a variety of diseases, including primary hepatocellular carcinoma, coronary atherosclerotic heart disease, deep vein thrombosis of the lower limbs, pulmonary tuberculosis, gastrointestinal bleeding, and so on\u003csup\u003e1\u0026ndash;4\u003c/sup\u003e. Interventional diagnosis and treatment approaches are classified into two types based on the access route used: vascular intervention and non-vascular intervention\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e,\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. Vascular interventions often use the femoral or radial artery as access\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. In comparison, radial artery puncture results in smaller wounds, easier compression to stop bleeding, and fewer limits on patient activities following operation. However, due to the radial artery's average lumen width of less than 3 mm, the access tube is tiny, prone to spasm and rupture, and frequently constricted during puncture\u003csup\u003e\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. The femoral artery has a greater diameter, a more fixed location, and a more prominent pulse; hence puncture success rates are frequently higher than those of the radial artery\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. The femoral artery puncture is the most often used method in clinical vascular interventional diagnosis and treatment\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003ePuncture Site Bleeding is the most common vascular consequence following femoral artery puncture, which might present as seeping of blood, subcutaneous hematoma, pseudoaneurysm, arteriovenous fistula, etc\u003csup\u003e\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. About 5% to 10% of patients will experience minor bleeding or subcutaneous hematoma following surgery, and approximately 1.5% of patients will experience unmanageable severe bleeding and require blood transfusion or even surgery\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. Manual compression hemostasis is the most traditional and commonly utilized method for hemostasis following femoral artery puncture\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThe requirements for postoperative hemostasis in the clinical guidelines for femoral artery puncture vary across countries and regions due to differences in factors affecting vascular hemostasis, such as coagulation ability, muscle contractility, and arterial blood pressure\u003csup\u003e\u003cspan additionalcitationids=\"CR21\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. In 2001, the American Heart Association and the American Heart Association Committee on Clinical Cardiology issued recommendations on postoperative hemostasis after femoral artery puncture, which recommended that the surgeon manually apply pressure to the puncture site for 10 to 20 minutes after femoral artery puncture and then have the patient immobilize the limb for 2 to 6 hours\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e. In the \"Chinese Clinical Practice Guidelines for Transarterial Chemoembolization of Liver Cancer\" published in China in 2021, it is recommended that surgeons manually press the femoral artery puncture site for at least 15 minutes after transarterial chemoembolization (transarterial chemoembolization,TACE) using the femoral artery approach and then use an elastic bandage for pressure dressing. After the operation, the patient needs to rest in bed and keep the lower limb on the puncture side immobilized for at least 6 to 12 hours.\u003c/p\u003e\u003cp\u003eProlonged immobilization can cause discomfort, delay treatment plans, and reduce bed utilization. Whether the postoperative immobilization time can be shortened is a question worth exploring. This study aimed to explore the feasibility of shortening the postoperative immobilization time after femoral artery puncture in Chinese population.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eHemostasis, compression, bandaging, and immobilization after femoral artery puncture are all closely associated with postoperative complications. We selected the best currently available hemostasis strategy, while maintaining consistent compression and bandaging conditions. Furthermore, we explored the possibility of shortening the postoperative immobilization time. To ensure effective hemostasis at the puncture site, we firstly screened for a hemostatic patch with superior hemostatic efficacy by in vitro hemostasis test. On this basis, we explored the possibility of shortening the immobilization time after femoral artery puncture in clinical practice (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eHemostasis, compression, bandaging, and immobilization after femoral artery puncture are all closely associated with postoperative complications. We selected the best currently available hemostasis strategy, while maintaining consistent compression and bandaging conditions. Furthermore, we explored the possibility of shortening the postoperative immobilization time.\u003c/p\u003e\u003cp\u003eTo ensure effective hemostasis at the puncture site, we screened a hemostatic product with superior hemostatic efficacy by in vitro hemostasis test. Through a rat tail transection experiment, after 1\u0026ndash;2 ml of blood was exuded from the wound, a 2 cm \u0026times; 2 cm three-layer sterile gauze or a 0.5 cm \u0026times; 0.5 cm chitosan hemostatic patch was applied to contact the blood and cover the wound (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA). The site was pressed for 2 minutes, and hemostatic effects were observed. If no anticoagulants were present in the rats' drinking water, no significant difference in hemostatic effect was found between the two hemostatic patches mainly composed of chitosan, and the hemostatic effect of both chitosan patches was significantly higher than that of sterile gauze (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eC). After pretreating rats with dual antiplatelet drugs, no significant difference in hemostatic effect was observed between the two chitosan hemostatic dressings, and both were still significantly more effective than sterile gauze (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eD). Therefore, it can be inferred that hemostatic dressings with chitosan as the main active ingredient have a better hemostatic effect compared to traditional sterile gauze, while there is no significant difference in hemostatic effect between the two chitosan dressings. These pieces of evidence indicate that Haemostatic dressings with kaolin are more effective at stopping bleeding than gauze. Since the two chitosan hemostatic products did not show differences in the rat tail amputation hemostasis experiment, we only selected chitosan hemostatic product A for subsequent experiments.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eA. Schematic diagram of rat tail hemostasis experiment. The experiment uses SPF-grade SD rats, which are pretreated with either antiplatelet drugs or an equal volume of pure water. After cutting off the tip of the rat's tail, hemostatic dressings are applied to stop the bleeding and construct the experimental model. The three hemostatic dressings used in this experiment are: sterile hemostatic gauze, chitosan hemostatic patch A, and chitosan hemostatic patch B. B. Schematic diagram of the main hemostatic mechanism of chitosan. The free amino groups of chitosan form positively charged groups, which, through interactions between positive and negative charges, adsorb negatively charged RBCs on the surface, causing them to aggregate into clusters and form a tight 'chitosan-RBC' complex. C. Comparison of hemostatic rates of three hemostatic dressings in a rat (pure water-fed) tail amputation hemostasis experiment with a pure water control group. D. Comparison of hemostatic rates of three hemostatic dressings in the rat (anticoagulant-fed) tail amputation bleeding experiment with pure water as the control group.\u003c/p\u003e\u003cp\u003eChitosan is a natural cationic polysaccharide rich in free amino groups, widely found in the shells of arthropods such as shrimp, crabs, and insects, in the cell membranes of algae, and in the cell walls of higher plants\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e,\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e. Chitosan possesses excellent hemostatic properties and good biocompatibility. Hemostatic dressings with chitosan as the main active ingredient have been used on battlefields to quickly control bleeding and have gradually expanded to civilian use in recent years. As a novel biological hemostatic material, research on the hemostatic mechanisms of chitosan has been extensively reported. Chitosan exhibits a complex, multifactorial synergistic hemostatic mechanism, including charge adsorption, platelet membrane receptor activation and coagulation factor release, and biological regulation\u003csup\u003e\u003cspan additionalcitationids=\"CR27\" citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e(Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eB). To further verify the hemostatic mechanism of chitosan hemostatic dressing A that we used, we made a glass trough and placed the hemostatic dressing at one end of the trough, analyzing the composition ratios of blood components at both ends. We defined the proximal end as the end of the rectangular glass trough closest to the hemostatic dressing, and the distal end as the end farthest from the hemostatic dressing. We measured the RBC, WBC, and PLT counts at both the proximal and distal ends of all samples (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eA and \u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eB). The results indicate that there are significant differences in the concentration distribution of RBCs (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eC) and PLTs (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eD) between the proximal and distal ends of Chitosan Hemostatic Patch A, suggesting that Chitosan Hemostatic Patch A can significantly induce the migration of RBCs and PLTs toward the proximal end in blood samples. In contrast, sterile hemostatic gauze shows a significant difference in PLT concentration but not in RBC concentration between the proximal and distal ends, indicating that sterile hemostatic gauze can only induce the migration of PLTs toward the proximal end(Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eE). Therefore, it can be concluded that Chitosan Hemostatic Patch A has a significant capacity to adsorb both RBCs and PLTs, whereas sterile hemostatic gauze mainly adsorbs PLTs. In addition, we observed that neither hemostatic dressing showed significant differences in WBC concentrations between the proximal and distal ends, suggesting that both have negligible adsorption capacity for WBCs. Blood is composed of plasma and three types of blood cells: RBCs, WBCs, and PLTs. Previous literature reports that chitosan mainly achieves rapid hemostasis by electrically attracting and aggregating RBCs locally\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e,\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e. In this study, we also observed that the RBC count at the proximal end of the Chitosan Hemostatic Patch A experimental group was lower than at the distal end, whereas the sterile hemostatic gauze showed no significant difference in RBC concentration between the proximal and distal ends(Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eG). This confirms that Chitosan Hemostatic Patch A has a far greater adsorption capacity for RBCs than sterile hemostatic gauze. Correspondingly, the total count of WBCs and PLTs at the proximal end of the Chitosan Hemostatic Patch A group was higher than at the distal end, and the proportion of non-red blood cells remaining in the glass trough at the proximal end was also higher than at the distal end(Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eC,\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eD,\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eE and \u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eF), demonstrating that Chitosan Hemostatic Patch A primarily adsorbed RBCs in the blood.\u003c/p\u003e\u003cp\u003eCompared with chitosan hemostatic patches, traditional sterile hemostatic gauze relies heavily on the body's inherent physiological hemostatic mechanisms. Therefore, when platelet (PLT) count is reduced or platelet function is abnormal, sterile hemostatic gauze often fails to achieve effective hemostasis. In clinical practice, patients with decreased PLT levels often face limitations when undergoing interventional procedures due to their poor coagulation function, suboptimal results from traditional manual compression hemostasis, and a higher risk of postoperative bleeding. The 2021 Chinese publication \"Clinical Practice Guidelines for Transarterial Chemoembolization in Hepatocellular Carcinoma\" clearly states that patients with a PLT count\u0026thinsp;\u0026lt;\u0026thinsp;50\u0026times;10\u003csup\u003e9\u003c/sup\u003e/L should first consider correcting the PLT deficiency before undergoing interventional procedures; if the patient has refractory PLT deficiency that cannot be corrected after treatment, interventional procedures are prohibited\u003csup\u003e\u003cspan additionalcitationids=\"CR32\" citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e. Chitosan hemostatic patch A does not rely entirely on the platelet-mediated hemostatic mechanism, allowing it to maintain certain hemostatic effects even in patients with impaired coagulation function. This feature is particularly significant for many patients with impaired coagulation due to infections, liver dysfunction, cancer, or myelosuppression caused by chemotherapy.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eA. Flowchart for preparing a blood cell migration experimental model. All glass wells were randomly assigned to the chitosan hemostatic patch experimental group and the sterile gauze control group. B. Schematic diagram of the preparation of the blood cell migration experimental model. Diluted fresh goat arterial blood is injected into a glass chamber, and at the proximal end of the glass chamber, a chitosan hemostatic patch A or sterile gauze is placed. After standing for 1 minute, blood samples are taken from the proximal and distal ends of the glass chamber to detect RBC, WBC, and PLT in the samples.C. Changes in RBC counts at proximal and distal sites under the influence of different hemostatic dressings. D. Changes in WBC counts at proximal and distal sites under the influence of different hemostatic dressings.E. Changes in PLT counts at proximal and distal sites under the influence of different hemostatic dressings. F. The proportions of different blood cell types at the proximal and distal sites under the influence of different hemostatic dressings. G. In vitro induced blood cell migration experiment: differences in blood cell distribution.\u003c/p\u003e\u003cp\u003eTo ensure effective hemostasis at the puncture site, we screened hemostatic dressings with superior hemostatic effects through in vitro hemostasis tests. Based on this, this study included 82 patients undergoing 5F femoral artery puncture from six domestic hospitals and according to the Central Randomization principle to randomly divide the enrolled patients into an early activity group and a late activity group (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eA and \u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eB). Among them, the early activity group included 41 patients, who had their limb immobilization removed and got out of bed 5\u0026ndash;6 hours postoperatively; the late activity group included 40 patients, who had their limb immobilization removed and got out of bed 8\u0026ndash;12 hours postoperatively (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eB).\u003c/p\u003e\u003cp\u003eThrough post-femoral artery puncture hemostasis experiments, we compared the differences in postoperative complication rates between patients with different immobilization durations and evaluated the safety of postoperative immobilization for patients in the early and late activity groups. We also analyzed hemostasis-related factors such as patients\u0026rsquo; preoperative RBC count, PLT count, and PT-INR, and explored the feasibility of using Chitosan Hemostatic Dressing A to shorten postoperative immobilization time for patients with certain coagulopathy.\u003c/p\u003e\u003cp\u003eStatistical analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e) of the baseline data of the included patients showed that there were no significant differences in demographic information such as gender, age, height, and weight between the two groups. In addition, we excluded factors that could affect hemostasis between different groups, such as diseases and medications, including hypertension, diabetes, thrombosis, atrial fibrillation, use of anticoagulants, bleeding, use of hemostatic drugs, tumors, and jaundice. The results showed that the clinical characteristics between the two groups were similar. Comparing hemostasis-related factors between the two groups of patients, the results showed no significant differences in preoperative RBC count, PLT count, or PT-INR. There were 11 patients whose baseline data were partially missing due to improper data storage, so they were not included in the final baseline characteristic comparison, but the results were included in the intention-to-treat analysis. A comparison of postoperative complication rates between patients with complete data and those with partially missing baseline data showed no statistically significant differences, indicating that the missing data were likely random and had limited impact on the overall results.\u003c/p\u003e\u003cp\u003e Based on guideline recommendations and the results of preliminary exploratory pre-experiments, we plan to randomly divide all enrolled patients into two groups. In the early mobilization group (n\u0026thinsp;=\u0026thinsp;41), patients' operative limb immobilization time post-surgery will be 5\u0026ndash;6 hours, while in the late mobilization group (n\u0026thinsp;=\u0026thinsp;40), immobilization time will be 8\u0026ndash;12 hours. Both groups will undergo right lower limb femoral artery puncture using a 5F arterial sheath and will receive hemostasis with chitosan hemostatic patches A postoperatively. Adverse reactions will be observed and recorded until 48 hours after the end of limb immobilization. By comparing the incidence of postoperative complications between the two groups with different immobilization durations, we evaluated the safety of postoperative immobilization in the early mobilization group versus the late mobilization group, with particular focus on the safety of postoperative immobilization in the early mobilization group.\u003c/p\u003e\u003cp\u003eClinical trial results showed no significant difference in the incidence of postoperative complications between patients in the early mobilization group and those in the late mobilization group (P\u0026thinsp;=\u0026thinsp;0.999, 95% CI: -2.6%-11.8%), suggesting that early mobilization (immobilization time 5\u0026ndash;6 hours) is safe for domestic patients undergoing 5F femoral artery puncture.\u003c/p\u003e\u003cp\u003eAmong the enrolled patients, only one case of subcutaneous hematoma occurred in the early mobilization group, with an overall postoperative complication rate of 1.23%; in the early mobilization group, the complication rate was 2.44%, which is not significantly higher compared with the 1.6%-31.4% incidence of vascular-related postoperative complications reported in some recent domestic studies on femoral artery punctures\u003csup\u003e\u003cspan additionalcitationids=\"CR35\" citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eFurthermore, none of the 81 enrolled patients exhibited other postoperative complications such as skin allergies, generalized pain, back stiffness or discomfort, urinary retention, deep vein thrombosis, infection, or vascular embolism, further demonstrating the safety of postoperative immobilization in the early mobilization group. Reducing immobilization time can help alleviate patient discomfort caused by immobilization, shorten hospital stay, and facilitate the implementation of outpatient interventional procedures.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eA. Sample Data Source Distribution Probability Chart. The enrolled patients come from 6 hospitals in China, accounting for 9%, 11%, 12%, 15%, 17%, and 36%, respectively. B. Flowchart of hemostasis after femoral artery puncture. This study included 81 patients aged\u0026thinsp;\u0026ge;\u0026thinsp;15 and \u0026lt;\u0026thinsp;90 years, of both sexes, with an expected survival of \u0026ge;\u0026thinsp;4 weeks, suitable for right lower limb femoral artery puncture using a 5F arterial sheath, and with a total surgery duration not exceeding 3 hours. Patients with severe coagulation disorders (PLT count\u0026thinsp;\u0026lt;\u0026thinsp;10\u0026times;10\u003csup\u003e9\u003c/sup\u003e), allergic diseases, or inability to control consciousness were excluded. Patients were randomized at the center into an early activity group (immobilization time of 5\u0026thinsp;~\u0026thinsp;6 hours) and a late activity group (immobilization time of 8\u0026thinsp;~\u0026thinsp;12 hours).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003ea.Baseline data were missing for 11 patients, who were not included in the final comparison of baseline characteristics; b, Baseline data were missing for 3 patients, who were not included in the final comparison of baseline characteristics.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eA. Comparison of Postoperative Complication Rates in Patients Undergoing Hemostasis Experiments After Femoral Artery Puncture. B. Comparison of Hemostasis-Related Factors in Patients Undergoing Femoral Artery Puncture Hemostasis Experiment. C-F, Hemostasis-related factors in patients undergoing femoral artery puncture hemostasis experiments. A. Some enrolled patients had a preoperative RBC count below the normal reference range. B. Some enrolled patients had a preoperative PLT count below the normal reference range. C. Some enrolled patients had a preoperative PT-INR above the normal reference range, D. Some enrolled patients received\u0026thinsp;\u0026ge;\u0026thinsp;1000U of heparin during the procedure; a. Data were missing for 11 patients; b. Data were missing for 3 patients.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study is to provide experimental evidence for optimizing postoperative hemostasis time by tentatively investigating the viability of reducing the hemostasis time following femoral artery puncture. It is based on the status of post-femoral artery puncture hemostasis in Chinese patients. First, we examined popular hemostatic dressings on the market and chose a hemostatic patch with chitosan as the primary active ingredient as the research topic in order to guarantee successful hemostasis at the puncture site. A common cationic polysaccharide found in nature, chitosan has free amino groups\u003csup\u003e\u003cspan additionalcitationids=\"CR38 CR39\" citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e. Previous studies have shown that chitosan has a complex, multifactorial synergistic hemostatic mechanism and is a new type of biologically valuable hemostatic material\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e,\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e,\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e. To screen for dressings with excellent hemostatic effects, we severed the tails of healthy adult rats and used sterile gauze and two types of chitosan hemostatic patches for hemostasis respectively, comparing the differences in hemostatic effects among different dressings. The results showed that the hemostatic effect of chitosan patches was significantly better than that of traditional sterile gauze, so chitosan hemostatic patch A was used for subsequent experiments. Subsequently, we designed a series of experiments to verify the hemostatic mechanism of chitosan hemostatic patch A. Previous studies have shown that numerous amino groups exist on the molecular chain of chitosan, which can form positively charged groups under physiological pH, attracting RBCs on the negatively charged surfaces of cell membranes, forming a \"chitosan-RBC\" tight complex within seconds. This mechanism does not depend on the activation of platelets (PLT) or the coagulation pathway, so hemostatic dressings containing chitosan can still exert a certain hemostatic effect even under conditions of impaired coagulation function. We placed chitosan hemostatic patch A on one side of a glass trough injected with diluted fresh goat arterial blood. After standing for 1 minute, blood samples were collected from both the ends near and far from the patch, and by comparing the distribution differences of RBCs, WBCs, and PLTs between proximal and distal samples, we verified that chitosan hemostatic patch A has a significant role in adsorbing RBCs in blood samples.\u003c/p\u003e\u003cp\u003eThe evidence we provide suggests that for domestic patients undergoing 5F femoral artery puncture, early ambulation (with a compression time of 5\u0026ndash;6 hours) is safe. Shortening the post-femoral artery puncture compression time is worth further confirmation in larger sample populations in the domestic setting.\u003c/p\u003e\u003cp\u003eMeanwhile, we have some limitations. Firstly, in our clinical trial optimizing hemostasis time after femoral artery puncture, we only selected patients undergoing the most common procedure using a 5F arterial sheath for femoral artery puncture as the study population. We did not include larger sheath sizes, nor did we include other common interventional access points such as the radial artery. Therefore, at present, we can only recommend the use of Chitosan Hemostatic Pad A for hemostasis and a 6-hour limb immobilization protocol after femoral artery puncture with a 5F sheath.For a standard randomized controlled trial (RCT) aiming to demonstrate a reduction in immobilization time to 5\u0026thinsp;~\u0026thinsp;6 hours, our rigorous calculations indicate that a minimum of 1,038 patients would be required. Limited by time and cost, this study included a smaller sample size, which weakens statistical power. Although we have preliminarily shown that a 5\u0026thinsp;~\u0026thinsp;6-hour immobilization time is safe in domestic patients undergoing 5F femoral artery puncture, reducing post-femoral artery puncture immobilization time in the domestic population still needs to be confirmed in larger-scale studies. Shortening the immobilization time will help alleviate patient discomfort caused by the tourniquet, shorten hospital stays, and support the outpatient implementation of interventional procedures. Selection bias may be introduced because some patients' baseline data is lacking. It is impossible to totally rule out the possibility that the missing data could have an impact on the outcomes, even if the data may be absent at random. Future studies should pay attention to data management measures to minimize the risk of baseline data loss. Finally, the clinical trial lacks long-term follow-up data. Whether the use of Chitosan Hemostatic Pad A increases the risk of hypercoagulable states or thrombosis in the long term remains unclear and requires further investigation.\u003c/p\u003e\u003cp\u003eOverall, Immobilization time shortening after femoral artery puncture in the Chinese population is potential which requires additional validation in a larger sample. This reduced immobilization time will serve to relieve patient discomfort, shorten the course of disease, and promote the development of outpatient interventional treatment.\u003c/p\u003e"},{"header":"STAR METHODS","content":"\u003cp\u003eDetailed methods are provided in the online version of this paper and include the following:\u003c/p\u003e\n\u003ch3\u003eMETHOD DETAILS\u003c/h3\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003eRat tail transection hemostasis experiment\u003c/h2\u003e\u003cp\u003eA total of 46 SPF-grade SD rats were selected, all male, each weighing 250\u0026thinsp;\u0026plusmn;\u0026thinsp;30 g, aged 8\u0026ndash;10 weeks. Prior to the experiment, they were adaptively housed in a temperature- and humidity-controlled animal room for 7 days, with free access to food and water. The animal room temperature was 22\u0026thinsp;\u0026plusmn;\u0026thinsp;1\u0026deg;C, and humidity was 50\u0026thinsp;\u0026plusmn;\u0026thinsp;5%. Using a random grouping method, 46 independent random numbers were generated by the random number generator in SPSS statistical software (version 25.0). After arranging the random numbers in ascending order, the first 22 rats were assigned to the antiplatelet drug pre-treatment group, and the remaining 24 rats were assigned to the pure water control group. Within each group, rats were further allocated using a systematic sampling method. The 22 rats in the antiplatelet drug pre-treatment group were divided into the sterile hemostatic gauze pre-treatment group (n\u0026thinsp;=\u0026thinsp;8), chitosan hemostatic patch A pre-treatment group (n\u0026thinsp;=\u0026thinsp;6), and chitosan hemostatic patch B pre-treatment group (n\u0026thinsp;=\u0026thinsp;8). The 24 rats in the pure water control group were divided into the sterile hemostatic gauze control group (n\u0026thinsp;=\u0026thinsp;8), chitosan hemostatic patch A control group (n\u0026thinsp;=\u0026thinsp;8), and chitosan hemostatic patch B control group (n\u0026thinsp;=\u0026thinsp;8).\u003c/p\u003e\u003cp\u003eAntiplatelet drug or pure water retreatment:(1) Take 100 mg of aspirin enteric-coated tablets and 75 mg of clopidogrel hydrogen sulfate tablets, place them in a 1000 ml beaker at room temperature, add 500 ml of purified water, and stir thoroughly with a glass rod until completely dissolved. Then, make up to 600 ml to obtain a dual antiplatelet drug suspension;(2) 24 hours before the experiment, add 200 ml of the dual antiplatelet drug suspension to the drinking bottles of the rats in the antiplatelet drug pretreatment group, while the pure water control group receives an equal volume of purified water. Both groups of rats are allowed to drink freely.1.2.3 Pre-experiment. Preparation (1) Fast the rats for 24 hours and water-deprive for 8 hours before the experiment;(2) Weigh and number each rat, and mark a positioning line for tail amputation approximately 2 cm from the tip of the tail with a medical marking pen. Then, transfer the rats to a room temperature environment and rest for at least 30 minutes;(3) Stack sterile hemostatic gauze in three layers and cut to a size of 2 cm \u0026times; 2 cm for later use. Cut two types of chitosan hemostatic dressings into 0.5 cm \u0026times; 0.5 cm pieces for later use.1.2.4 Establishment of Rat Tail Amputation Hemostasis Model(1) Hold the rat with its belly facing up and head slightly lower than the body;(2) According to the rat\u0026rsquo;s weight, use a 2 ml sterile syringe to draw 3 ml/kg of 10% chloral hydrate solution;(3) Perform intraperitoneal anesthesia in the lower left quadrant of the rat\u0026rsquo;s lower abdomen, avoiding the bladder and midline abdominal vessels. Insert the syringe needle at a 30\u0026deg; angle to the skin until it enters the abdominal cavity. Aspirate to confirm no blood or fluid reflux, then slowly inject the 10% chloral hydrate solution. After injection, gently press the needle puncture site to prevent leakage;(3) Observe for 10 minutes. Successful anesthesia is indicated by relaxed muscles and reduced pain response in the rat;(4) Place the anesthetized rat in a prone position on the surgical table, and disinfect the skin at the tail apex positioning line with a 75% medical alcohol cotton ball in a circular manner three times, each interval 30 seconds;(5) Clamp the tail above the positioning line with hemostatic forceps for 30 seconds, then quickly amputate vertically at the positioning line with a surgical knife;(6) After 1\u0026ndash;2 ml of blood oozes from the tail wound, use the 2 cm \u0026times; 2 cm three-layer sterile gauze or 0.5 cm \u0026times; 0.5 cm chitosan hemostatic dressing to cover the wound and press for 2 minutes to stop bleeding without interruption. Alternatively, remove the dressing to observe hemostasis. Rats in the sterile gauze pretreatment and control groups use sterile gauze for hemostasis; rats in the chitosan dressing A pretreatment and control groups use chitosan dressing A; rats in the chitosan dressing B pretreatment and control groups use chitosan dressing B. The hemostatic effect was recorded and analyzed. Data were statistically analyzed using SPSS software (version 25.0). Categorical data were expressed as counts and percentages. The chi-square test or Fisher's exact test was used to compare whether there were statistically significant differences in the hemostatic effects of three different hemostatic dressings on rat tail amputation wounds between the antiplatelet pretreatment group and the pure water control group. All tests were two-sided, and P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eBlood cell migration assay\u003c/h3\u003e\n\u003cp\u003eCollect 10 ml of fresh goat arterial blood within 1 hour and place it in a 200 ml beaker at room temperature. Dilute it with 0.9% saline at a 1:10 volume ratio and stir thoroughly with a glass rod for 10 seconds. Using a micropipette, take the diluted fresh blood and randomly assign it into groups. Six independent random numbers were generated using the random number generator in SPSS statistical software (version 25.0). After arranging the random numbers in ascending order, the first three of the six glass troughs containing the diluted fresh goat arterial blood were assigned to the chitosan hemostatic patch experimental group, and the remaining three were assigned to the sterile hemostatic gauze control group. The two ends of each rectangular glass trough, which are the farthest apart, were labeled as the proximal and distal ends, respectively. Cut chitosan hemostatic patch A and three-layer stacked sterile hemostatic gauze into 2 cm \u0026times; 2 cm pieces. Place the cut chitosan hemostatic patch A at the proximal end of the glass trough in the experimental group, closely adhered to the glass, and place the three-layer stacked sterile hemostatic gauze at the proximal end of the glass trough in the control group, closely adhered to the glass. Let them sit for 1 minute. Then, using a 2 ml sterile syringe, collect 2 ml samples of the diluted fresh goat arterial blood from both the proximal and distal ends of each glass trough, as shown in Figs.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e and \u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e, to test the RBC, WBC, and PLT counts for all samples.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eExperimental Data Statistics and Analysis\u003c/h2\u003e\u003cp\u003eData were statistically analyzed using SPSS software (version 25.0). Categorical data were expressed as counts and percentages. The chi-square test or Fisher's exact test was used to compare whether there were statistically significant differences in the hemostatic effects of three different hemostatic dressings on rat tail amputation wounds between the antiplatelet drug pretreatment group and the pure water control group. All tests were two-sided, and P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eClinical sample collection\u003c/h3\u003e\n\u003cp\u003eA total of 82 patients who underwent right lower limb femoral artery puncture with a 5F arterial sheath in six domestic hospitals from September 2022 to March 2025 were selected. According to the inclusion and exclusion criteria described below, 81 patients were ultimately included in the study.\u003c/p\u003e\u003cp\u003eInclusion Criteria:a. Patients aged\u0026thinsp;\u0026ge;\u0026thinsp;15 years and \u0026lt;\u0026thinsp;90 years, of any gender;b. Patients with an expected life expectancy of \u0026ge;\u0026thinsp;4 weeks;c. Patients suitable for right lower limb femoral artery puncture using a 5F arterial sheath;d. Total surgery duration not exceeding 3 hours.\u003c/p\u003e\u003cp\u003eExclusion Criteria:a. Patients with severe coagulation disorders (PLT count\u0026thinsp;\u0026lt;\u0026thinsp;10\u0026times;10\u003csup\u003e9\u003c/sup\u003e); b. Patients with allergic diseases;c. Patients unable to maintain self-awareness even with the assistance of family members.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eRESOURCE AVAILABILITY\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLead contact\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFurther information and requests for resources should be directed to and will be fulfilled by the lead contact, Jingjing Li ([email protected]).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study did not generate new unique reagents.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData and code availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data reported in this paper will be shared by the lead contact upon request.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis article does not report the original code.\u003c/p\u003e\n\u003cp\u003eAny additional information required to reanalyze the data reported in this article is available from the lead contact upon request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAUTHORCONTRIBUTIONS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJingjing Li and Feng designed the research; Qiang Zou, Guangyue Bai, Kang Liu, Guiqing Li, Yi Zheng, Liang Zhu, Wenjun Li, Shuqing Wang, Heng Zhang, Yuntao Wang, Chunyan Tang, Xueqin Wang and Xueqin Wu performed the experiments. Jingjing LI, Feng Liu and Yuntao Wang wrote and organized the manuscript; Jingjing Li, and Feng Liu revised the manuscript and reorganized the figures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDECLARATION OF INTERESTS\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eapproval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe animal experiments involved in this study were all approved by the Ethics Committee of the Affiliated Hospital of Shandong Second Medical University. The clinical trials involved in this study were approved by the Medical Ethics Committee of the Second Medical University of Shandong Affiliated Hospital (NO. wyfy-2022-ky-249) and the National Medical Research Registration Information System (MR-37-24-028084). All patients provided verbal or written informed consent before enrollment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent was obtained from all individual participants included in the study. The consent form explicitly stated that the participants' data (including any potentially identifying information such as images or case details) would be published in a scientific journal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eACKNOWLEDGMENTS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this work Jingjing Li and Feng Liu is supported by the National Natural Science Foundation of China (Grant No. 82104289), Shandong Provincial Health Commission(M-2022053), Science and Technology Innovation Plan from Weifang Medical University (041004), Yuandu Scholar Grant of Weifang City to LJJ, Weifang Science and Technology Bureau Plan Project (2021YX081), Science and technology project jointly established by the Science and Technology Department of the State Administration of Traditional Chinese Medicine (GZY-KJS-SD-2023-079), Shandong Provincial Medical Association Young Talent Promotion Project (2023_GJ_0039). Science and Technology Innovation Plan from Weifang Medical University (041011). We acknowledge Tricol Biomedical for supplying the chitosan patches (HemCon Patch® PRO ,1076).\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eYao L et al (2025) Application of Nanotechnology in TACE Treatment of Liver Cancer. 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Theranostics 13:161\u0026ndash;196. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.7150/thno.79639\u003c/span\u003e\u003cspan address=\"10.7150/thno.79639\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"shandong secoundary medical university","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Femoral artery puncture, Immobilization time, Chitin, Haemostasis, TACE","lastPublishedDoi":"10.21203/rs.3.rs-8288517/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8288517/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003e According to the Chinese \"Clinical Practice Guidelines for Transarterial Chemoembolization of Liver Cancer\" (Version 2021), the operative limb should be immobilized for 6\u0026ndash;12 hours following femoral arterial puncture. In 2001, the American Heart Association and its Committee on Clinical Cardiology recommended immobilizing the surgical limb for 2\u0026ndash;6 hours. Prolonged immobilization might create discomfort, defer treatment plans, and reduce bed utilization. It is worth investigating whether the Chinese population's postoperative immobilization period might be reduced. The purpose of this study was to determine the feasibility of shortening the postoperative immobilization time following femoral artery puncture.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eHemostasis, compression, bandaging, and immobility following femoral artery puncture are all linked to postoperative problems. We chose the best current hemostasis approach while keeping consistent compression and bandaging circumstances. Furthermore, we investigated the possibility of reducing postoperative immobilization time. To ensure adequate hemostasis at the puncture site, we used an in vitro hemostasis test to find a hemostatic patch with greater efficiency. On this basis, we investigated the prospect of shortening the immobilization period following femoral artery puncture. We enrolled 82 individuals who agreed to a 5F femoral artery puncture from six hospitals in China. Accoring to the Central Randomization principle, patients were randomly assigned to one of the two groups: early mobilization (immobilization time: 5\u0026thinsp;~\u0026thinsp;6 hours) or late mobilization (8\u0026thinsp;~\u0026thinsp;12 hours). The rates of complications, such as postoperative puncture site hemorrhage and subcutaneous hematoma, were compared between them.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eIn the hemostasis effect test assay, the chitin hemostatic patch shows a better hemostatic effect than gauze and was thus chosen as the fixed condition for the hemostatic stages in subsequent investigations. The complication ratio after femoral artery puncture did not differ significantly between individuals randomly assigned to early or late mobilization (P\u0026thinsp;=\u0026thinsp;0.999, 95% CI: -2.6%~11.8%). Early mobilization is safe for individuals undergoing 5F femoral artery puncture in included Chinese population.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eImmobilization time shortening after femoral artery puncture in the Chinese population is potential which requires additional validation in a larger sample. This reduced immobilization time will serve to relieve patient discomfort, shorten the course of disease, and promote the development of outpatient interventional treatment.\u003c/p\u003e","manuscriptTitle":"A Preliminary Study on Shortening the Postoperative Immobilization Time after Femoral Artery Puncture in the Chinese Population","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-09 07:16:27","doi":"10.21203/rs.3.rs-8288517/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ceb961de-749f-4e19-8621-bbd1ae8eb6ab","owner":[],"postedDate":"December 9th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-12-09T07:16:27+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-09 07:16:27","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8288517","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8288517","identity":"rs-8288517","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}