“Assessment of the utilization of fresh frozen plasma in a training and research hospital: What does the high level of inappropriate use tell us?” A descriptive-analytical study with cross-sectional method.

“Assessment of the utilization of fresh frozen plasma in a training and research hospital: What does the high level of inappropriate use tell us?” A descriptive-analytical study with cross-sectional method. | 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 “Assessment of the utilization of fresh frozen plasma in a training and research hospital: What does the high level of inappropriate use tell us?” A descriptive-analytical study with cross-sectional method. Murat Yazici, Soner Yilmaz, Dilek Gurlek Gokcebay, Sahin Kaymak, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5392902/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Objective: Fresh frozen plasma (FFP) is a life-saving treatment agent when used correctly, but it is also the one which is the most inappropriately used among the blood components. The aim of this study is to evaluate FFP transfusion indications based on different clinics. Methods: The study was carried out with the data obtained as a result of retrospective reviewing of the data of a total of 500 patients from 10 different clinics. FFP Transfusion Evaluation Form was created after scanning national/international articles, guidelines, and similar publications regarding the use of FFP. Results: It was determined that FFP was used at a rate of 26.6 % within appropriate indications. In terms of mortality development, there was no difference between the indication groups (p=0,31). There was no difference between the indication groups in the number of cases in which INR decreased with FFP transfusion (p=0,14). While the mean aPTT levels decreased from 48,2±32,1 to 31±15,4 (p<0,01) after transfusion, the mean INR values decreased from 3,6±3,8 to 1,6±0,8 (p< 0,04). Conclusion: The high rate of inappropriate use of FFP both threatens patient health due to transfusion reactions and affects stock management in blood centers adversely. The results obtained from the study reveal that standards and guidelines should be established for the appropriate use of FFP, both on a hospital and hospital basis, and the process should be audited at regular intervals in terms of ensuring clinicians' compliance with them and appropriate use. Fresh frozen plasma transfusion coagulation mortality Figures Figure 1 Figure 2 Introductıon Fresh frozen plasma (FFP) is a blood component prepared by freezing plasma, obtained from either whole blood or apheresis, at a temperature and duration that allows plasma proteins, particularly clotting factors, to maintain their functions. It contains clotting factors, immunoglobulins, and albumin. FFP is generally transfused for two main indications: to prevent bleeding (prophylactic) and to treat bleeding (therapeutic) [1]. In the "Model for Estimating Blood Supply and Demand for the Purpose of Determining the Need for Change in Blood Transfusion Centers" study within the scope of the "Technical Assistance for the Improvement of the Transfusion Management System in Turkey" project carried out between 2019 and 2022, FFP was ranked second with a usage rate of 25% of all blood and blood components transfused in 2019 [2]. FFP is considered to be a 'high-risk' blood component in terms of its potential to cause transfusion reactions [3]. According to 2021 Serious Hazards of Transfusion (SHOT) data, there is one transfusion reaction accounted for 1 per 10,000 FFP transfusions [4]. Additionally, FFP is the most commonly misused or inappropriately indicated blood component [5]. This situation complicates FFP stock management, leads to unnecessary costs, and, most importantly, exposes patients to transfusion risks. Despite the presence of numerous guidelines on the clinical usage of blood components, a high rate of reports of inappropriate FFP usage is still reported in the literatüre [6]. In this study, our aim was to assess the appropriateness and rationalization of FFP use on a clinical basis at Gülhane Training and Research Hospital. Materials and Methods This study was carried out in accordance with the Gülhane Scientific Research Ethics Committee (2020-344). Authors declare that the study was conducted in accordance with the Declaration of Helsinki and followed the ethical standards of Türkiye Study Group The study was conducted on patients who were hospitalized and received FFP transfusions as part of their treatment at Gülhane Training and Research Hospital between 01 September 2020 and 01 September 2021. A total of ten departments in which FFP was used most according to the previous year's data were included in this study. As all of the data on cardiovascular surgery were obtained from patients undergoing bypass surgery, these data were excluded from the study. Fifteen patient files from each department were screened retrospectively to achieve a sample size determined by power analysis. Demographic data (age and sex), diagnoses, surgical interventions (if any), active bleeding sites, coagulation parameter test results (PT, aPTT, INR), co-morbidities, and clinical outcomes (discharged, exitus) were retrieved from the hospital software system and medical records. Formation of the FFP Transfusion Evaluation Form The College of American Pathologists (CAP)/British Committee for Standards in Haematology (BCSH) guidelines, and similar studies were used to classify the clinical use of FFP [7-11]. Accordingly, FFP indications were divided into three groups as follows: appropriate, inappropriate, and partially appropriate FFP usage. The FFP Transfusion Evaluation Form form has been developed with the scientific expertise of a hematologist and a pediatric hematologist. This form was completed by a physician from each clinic participating in the study. Statistical Analysis Continuous variables (demographic data and laboratory findings) were presented with descriptive statistics (M-mean, SD-standard deviation, min-minimum, max-maximum). Categorical variables were shown as numbers and percentages. The chi-square statistic was used to show whether or not there is a relationship between two categorical variables. The Fisher's Exact test was employed to analyze 2x2 groups formed by categorical variables. The Student's t-test was applied for the analysis of groups formed by continuous variables. The p value was accepted <0.05 for statistical significance. The sample size was estimated based on data from the literature and conducted assuming a power (1 − β ) of 0.80 and α = 0.05 (6,11). Results A total of 500 patients were included in the study, of whom 239 (47.8%) were male and 261 (52.2%) were female. The mean age (min-max) for males was 50.8 years (1-94) and for females 53.1 years (2-98). Analysis of the appropriateness of FFP transfusions showed that of the 500 cases, 26.6% (133/500) had appropriate indications, while 72.6% (363/500) had inappropriate indications. The remaining 4 cases were part of a partially correct classification. Among the inappropriate indications, the most commonly reported indications were the “Use of more than 1 unit of EC (excluding massive transfusion) follwing “pre-transfusion INR 1.5 and/or prolonged PT/aPTT and no bleeding or surgery/procedure”. “Peri-surgical bleeding and pre- or post-transfusion INR > 1.5 and /or prolonged PT/aPTT waas the most common indications among the appropriate indications (Table 1). Upon examination of FFP usage among clinics, it has been determined that the Department of Emergency Medicine is the most appropriate setting for FFP use at a rate of 50% usage. In contrast, the Department of Obstetrics and Gynecology demonstrated the highest level of inappropriate usage at a rate of 4% (Figure 1). A total of 367 patients had an underlying disease. The main underlying reasons diseases were The most common underlying diseases in those who used FFP inappropriately were gastrointestinal (GI) malignancies (53/367, %14), trauma (32/367, 9%), and hematological malignancies (29/367, 8%) (Figure 2). There were a total of 257 patients whose coagulation parameters were tested before and after the transfusion. In this group of patients, before FFP transfusion, aPTT and INR values (mean±SD) were 37±24 and 2.2±1.4, respectively, whereas after transfusion these values were 29.4±13.4 and 1.4±0.7, respectively. A statistically significant decrease was observed for both test parameters (p<0.01). Of these, only 50 cases had a post-operative INR below 1.5. The mortality rate was determined as 18.4% (408/500). This rate was found to be 21% (28/133) in patients where FFP was used appropriately, 17% (62/363) in patients where it was not used appropriately, and 50% (2/4) in partially appropriate usage cases. The statistical analysis did not show a significant difference in the rate of mortality between these three patient groups (p=0.157). Discussion The inappropriate use of FFP not only leads to transfusion reactions but also causes significant stock management problems for blood centers. These are some of the key concerns around this topic. There have been numerous studies worldwide investigating the inappropriate use of FFP and the underlying reasons. In these studies, the rate of inappropriate use of FFP varies from 21.3% to 83% [3,12]. The wide range of this rate may be due to the guidelines used, clinics where the study was conducted, and possible variability in the number of patients. Considering the available data, it is possible to say that the 72.6% rate obtained in our study is relatively high. This high rate is an indication that precautions should be in place in our hospital with regard to this issue. In this context, we plan to first share the existing data of the clinics with them, then encourage the clinicians to use the existing guidelines through the training sessions that we will organize, and to monitor the issue closely with regular follow-ups. Determining the reasons for inappropriate use of FFP is very important in solving this problem. In the study by Tinmouth and colleagues, the most common (54.8%) indications leading to inappropriate use was “INR 1.1-1.5 before transfusion / normal PTT (and normal PTT after transfusion, if available). Irrespective of bleeding status or procedure status” [11]. Similarly, in the study by Lingegowda and colleagues, “surgical conditions in which the coagulation profile is normal or slightly elevated” (48%) are the most frequent indication for inappropriate use [6]. Reviewing the data from our study, it can be said that clinicians tend to add FFP transfusion to EC transfusion when there is no critical or massive bleeding. After having the study data, discussions with physicians working in the relevant clinics revealed that this indication is applied under the assumption that the severity of bleeding in patients with trauma or perioperative bleeding cannot be predicted in advance or INR results may poorly reflect the actual coagulation profile. So, it is considered that the purpose of FFP administration in addition to EC transfusion in patients without active bleeding is prophylaxis or prevention of the development of dilutional coagulopathy. The availability of viscoelastic tests in the operating room, which best reflects the patient's coagulation profile during surgery, could significantly reduce inappropriate usage for these patients. There are also findings in the literature regarding the clinic-based evaluation of FFP usage. In a study of obstetric patients by Puri and colleagues, the most common reason (33/40; 82.5%) for inappropriate use of FFP was severe anemia [12]. Obstetrics and gynecology stand out among clinics with the highest rate of inappropriate FFP requests in our study. When the data of these patients are examined, it is seen that FFP was used inappropriately in 36 patients during various obstetric and surgical procedures without the need for massive transfusion. The second most common cause of inappropriate use is the use of FFP as a volume expander, with 10 cases. The use of fresh frozen plasma is contraindicated if the blood volume can be adequately replaced with other volume expanders. The second clinic in which inappropriate use occurred most frequently was the Orthopedic and Traumatology. Among a total of 47 inappropriate use in this clinic, the most frequent indication is "the patient receiving more than 1 unit of red blood cell concentrate without massive transfusion along with FFP" accounting for 32 cases, followed by the indication of "volume replacement" with 13 cases. Particularly, in the detailed evaluation of the first indication, it was observed that INR values were measured before and after surgery in all patients, and only two cases had values above 1.5. FFP transfusion was performed in these patients to prevent the coagulation profile from being impaired by EC transfusion due to the risk of post-operative intramedullary hemorrhage, even though there was no evidence of active hemorrhage [Ö. Erşen, 2023, pers.com.] Of the 32 cases of inappropriate FFP use detected in the hematology clinic, factor deficiency was identified in 9 cases. Particularly in this patient group, the possible reasons for inappropriate usage can be summarized as follows: patients with factor 8 or 9 levels below 1% have an indication for routine prophylaxis treatment, while patients with factor levels >1% have an indication for use of specific coagulation factors for prophylaxis before surgery or in the event of recurrent bleeding. Being aware of how to use your own available coagulation factors in the event of bleeding, and being able to reach the medical facilities where bleeding is well managed, will increase the use of specific coagulation factor products instead of FFP. In patients with hemophilia A or B with factor levels >5%, who do not require prophylactic treatment and do not have a significant bleeding diathesis, FFP is more often preferred for surgical prophylaxis or emergency treatment of bleeding. Especially for those patients, factors related to the use of FFP instead of specific factor concentrates include the unavailability of specific coagulation factors in many healthcare centers, the need for a prescription for the use of specific coagulation factors, the low level of knowledge about bleeding management in patients with mild hemophilia, and the easier accessibility of FFP in emergency situations. Evaluating coagulation test parameters is an important factor for determining appropriate indications for FFP transfusion. Generally, a 1.1-1.5-fold increase in PT/INR and aPTT values is considered sufficient for FFP transfusion [13]. However, especially during the perioperative period, this increase in coagulation parameters may not always have clinical significance. The non-linear relationship between coagulation factor levels and test results could be attributed to the fact that even in normal individuals test results may show an increase. Additionally, it is important to note that these tests are designed to assess fibrin formation, not predict bleeding. Therefore, when evaluating FFP transfusion indications based on coagulation test results, caution should be exercised, and the overall clinical context should be taken into consideration [9, 10].A decrease in PT and INR of 0.2 and 1.9 seconds, respectively, before and after transfusion was observed in a series of 4635 patients studied by Stanworth et al.[1]. A statistically significant decrease of 0.1 seconds in INR and 1.4 seconds in aPTT was observed in the study by Sugiyama et al.[14]. In our study, there was a statistically significant decrease of 7.6 and 0.8 seconds in aPTT and INR values before and after transfusion, respectively. Although the guidelines used for this study consider the results of coagulation tests as limiting values or determinants for FFP transfusion, it is possible to observe a change in this approach in current studies or in newly published treatment guidelines. In the latest guidelines published by the Japanese Ministry of Health on this subject, it is stated that there is no need to perform coagulation tests before FFP transfusion [14]. Additionally, especially for perioperative bleeding or trauma patients, it is considered a more accurate approach to use viscoelastic tests to assess transfusion needs and determine the current coagulation profile. Malignancy and trauma come to the fore when examining the diseases of the patients in whom FFP was used inappropriately in our study. In Sugiyama's study investigating inappropriate FFP usage, the top three underlying diseases were cardiovascular surgery cases, followed by gastrointestinal bleeding and colorectal cancers [14]. The results appear to be similar when considering that our study did not include cases of cardiovascular surgery. The prominence of gastrointestinal malignancies may be due to the fact that these patients are treated in different clinics such as medical oncology, general surgery, and gastroenterology. The mortality rate was 18% when all patients in the study were considered. In two different studies investigating FFP usage in emergency departments in our country, the mortality rates were found to be 7.2% and 6.4% [15, 16]. In a study conducted in Japan, this rate was reported as 16.2% [14]. In our study, there was no statistically significant difference in mortality between the groups of patients in whom FFP was used appropriately and those in whom it was not used. However, independent factors such as age, number of FFP units transfused, and high post-transfusion INR and PTT levels, which may influence mortality, should also be evaluated to accurately assess the relationship between FFP use and mortality. This study is subject to several limitations. The retrospective design should be considered in this context. Another limitation is the unavailability of coagulation test results for all patients. Conclusion Despite the existence of numerous national/international guidelines on the use of FFP, it has been observed that clinicians do not follow these guidelines to the desired level. Furthermore, having guidelines to help guide the correct indications alone is not enough. There is an absolute need to develop new strategies that include continuous training and monitoring processes. Transfusion committees should play a more active role in the use of blood and blood components. To this end, internal audit mechanisms should be put in place and data relating to the use of FFP should be monitored on a regular basis. Declarations Acknowledgement: We would like to thank medical doctors Mesudiye Bulut, Murat Yıldırım, Ulaş Fidan, Levent Yamanel, Musa Barış Aykan, Orhan Gürsel, Ömer Erşen, Harun Erdal, and Umut Kara for their contributions to the study. Conflict of Interest: None declared. Financial Disclosure: The author declared that this study has received no financial support. Author Contribution Author contribution:Concept: M.Y. and S.Y. and D.G.G. Design: M.Y. and S.Y. and D.G.G.Data Collection or Processing: E.S.Y. and S.K. and G.A. and I.Y.A.Analysis or Interpretation: S.K. and U.Y.Literature Search: S.K. and U.Y. and G.A.Writing: M.Y. and S.Y. References Stanworth SJ, Grant-Casey J, Lowe D, Laffan M, New H, Murphy MF, AllardS. The use of fresh-frozen plasma in England: high levels of inappropriate use in adults and children. Transfusion 2011;51(1), 62-70. T.C. Sağlık Bakanlığı, Türkiye’de Kan Transfüzyon Yönetim Sisteminin Geliştirilmesi için Teknik Yardım Projesi , Kan Hizmet Birimlerinde Değişim İhtiyaçlarının Belirlenmesine Yönelik Kan Arz ve Talebi Tahmin Modeli Accessed 20 September 2023. https://hastakanyonetimi.saglik.gov.tr/Content/ListIndex/?id=1019 Pahuja S, Sethi N, Singh S, Sharma S, Jain M, Kushwaha S. Concurrent audit of fresh frozen plasma: experience of a tertiary care hospital. Hematology 2012;17(5), 306-310. S Narayan (Ed) D Poles et al. on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2021 Annual SHOT Report (2022). Lanzoni M, Olivero B, Artoni A, Marconi M, Raspollini E, Castaldi S. Use of fresh-frozen plasma in 2012 at the Fondazione Ca' Granda Hospital of Milan: assessment of appropriateness using record linkage techniques applied to data routinely recorded in various hospital information systems. Blood Transfus. 2018;16(3):253-261. Lingegowda JB, Jeyakumar JD, Muddegowda PH, Pitchai R, Gopal N, Sinha P. An Audit of Requests for Fresh Frozen Plasma in a Tertiary Care Center in South India. J Lab Physicians. 2016;8(1):41-44. Kanın Uygun Klinik Kullanım Rehberi. Kan ve Kan Ürünleri Dairesi Başkanlığı, Ankara 2020. Accessed 20 September 2023. https://dosyamerkez.saglik.gov.tr/Eklenti/37459/0/kanin-uygun-klinik-kullanimi-rehberi-kukk--23-mayis-2020pdf.pdf Lundberg GD. Guidelines P. Practice parameters for the use of fresh-frozen plasma. J Am Med Assoc. 1994;271(3). Bolton-Maggs P, Beattie C, Cardigan R, Kallis Y, Stanworth SJ, Green L. Corrigendum to British Society of Haematology Guidelines on the spectrum of fresh frozen plasma and cryoprecipitate products: their handling and use in various patient groups in the absence of major bleeding British. J Haematol. 2018;181(1):54e67. Wong MP, Droubatchevskaia N, Chipperfield KM, Wadsworth LD, Ferguson DJ. Guidelines for frozen plasma transfusion. B C Med J. 2007;49(6):311e319. Tinmouth A, Thompson T, Arnold DM, Callum JL, Gagliardi K, Lauzon D, Owens W, Pinkerton P. Utilization of frozen plasma in Ontario: a provincewide audit reveals a high rate of inappropriate transfusions. Transfusion 2013;53:2222–9 Puri V, Dhal I, Singh K, Sharma G, Rai P, Sharma S. Critical audit of fresh frozen plasma transfusion practices in obstetric and gynecology departments in a tertiary care hospital–Where and what needs to be improved? Glob J of Transf Med 2019; 4(2), 175. Kumar S, Kushwaha N, Tomar A, Philip J, Biswas AK. A retrospective audit to evaluate the appropriateness and rationalization of Fresh Frozen Plasma usage in a tertiary care hospital. Med J Armed Forces India 2022;78, S226-S231. Sugiyama A, Fujii T, Okikawa Y, Sasaki F, Okajima M, Hidaka H et al. Outcomes of patients who undergo transfusion of fresh frozen plasma: a prospective, observational, multicentre cohort study in Hiroshima, Japan. J Blood Med 2021; 965-973 Emektar E, Dagar S, Corbacioglu SK, Uzunosmanoglu H, Oncul MV, Cevik Y. The evaluation of the audit of Fresh-Frozen Plasma (FFP) usage in the emergency department. Turk J Emerg Med 2016;16(4), 137-140. Karamurat M, Durak VA, Köksal Ö. Bir Üniversite Hastanesi Acil Servisi'nde Taze Donmuş Plazma (TDP) Verilen Hastaların Retrospektif Analizi. Uludağ Tıp Derg. 2018; 44(3), 197-202. Tables Table 1. Classification of FFP trnasfusions FFP Transfusion Indications N (%) Inappropriate Indications Use of more than 1 unit of EC (excluding massive transfusion). Pre-transfusion INR 1.5 and/or prolonged PT/aPTT and no bleeding or surgery/procedure 47 (9,4) Pre-transfusion INR 1.1-1.5. Irrespective of bleeding status or procedure status 45 (9) Volume replacement 32 (6.4) Liver disease pre- or post-transfusion INR > 1.5 and/or prolonged PT/aPTT and no bleeding or surgery/procedure 29 (6) Hemophilia A/B 12 (2.4) Reversal of warfarin effect and no bleeding or going for an invasive procedure/surgery 10 (2) Pre-paracentesis / Hypoalbuminemia 3 (0.6) Total 363 (72.6) Appropriate Indications Peri-surgical bleeding and pre- or post-transfusion INR > 1.5 and /or prolonged PT/aPTT 29 (5,8) Liver disease (prolonged PT/aPTT or INR > 1.5) with bleeding or going for an invasive procedure/surgery 19 (3.8) Massive transfusion and pre- or post-transfusion INR > 1.5 and/or prolonged PT/aPTT 19 (3.8) DIC/Multiple coagulation factor deficiencies (INR > 1.5 and/or prolonged PT/aPTT) associated with bleeding or going for an invasive procedure/surgery 18 (3.6) Reversal of warfarin effect, only in cases of bleeding or prior to an invasive procedure 23 (4,6) Inherited deficiencies of individual coagulation factors (factor XI, protein C, antithrombin III, etc.) for which there is no specific factor concentrate available 15 (3) Thrombotic Thrombocytopenic Purpura 9 (1.8) Hereditary Angioedema 1 (0.2) Total Partial Correct Indication 133 (26.6) No laboratory coagulation data pre- or –post-transfusion 4 (0.8) Total 4 (0.8) Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 12 Jan, 2025 Reviews received at journal 30 Dec, 2024 Reviews received at journal 20 Dec, 2024 Reviewers agreed at journal 15 Dec, 2024 Reviewers agreed at journal 10 Dec, 2024 Reviewers invited by journal 10 Dec, 2024 Editor assigned by journal 08 Nov, 2024 Submission checks completed at journal 08 Nov, 2024 First submitted to journal 05 Nov, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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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-5392902","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":382730187,"identity":"b68ba4db-64fb-4742-b5d3-d2a49067f431","order_by":0,"name":"Murat 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Avci","email":"","orcid":"","institution":"University of Health Sciences, Gülhane Training and Research Hospital, Department of Infectious Disease and Clinical Microbiology","correspondingAuthor":false,"prefix":"","firstName":"İsmail","middleName":"Yasar","lastName":"Avci","suffix":""}],"badges":[],"createdAt":"2024-11-05 07:08:12","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5392902/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5392902/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":71144609,"identity":"198e0196-478b-4fbb-ac16-b49b5c34eddd","added_by":"auto","created_at":"2024-12-11 14:12:47","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":49833,"visible":true,"origin":"","legend":"\u003cp\u003eDistribution of appropriate/inappropriate use of FFP according to departments.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5392902/v1/b10f0feab7e8f8d5db3dc1e3.png"},{"id":71144608,"identity":"808bd038-1ffb-4884-b7bb-538ae3e702b4","added_by":"auto","created_at":"2024-12-11 14:12:47","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":32436,"visible":true,"origin":"","legend":"\u003cp\u003eUnderlying disease in which the reason for the use of FFP was considered \"inappropriate\".\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5392902/v1/9603dd225332c8601d30ab2b.png"},{"id":71144610,"identity":"dcd280d9-30fb-4858-91bf-781b2c800842","added_by":"auto","created_at":"2024-12-11 14:12:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":324627,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5392902/v1/41e0b2e0-1189-4ad7-a5d2-1593ad955709.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"“Assessment of the utilization of fresh frozen plasma in a training and research hospital: What does the high level of inappropriate use tell us?” A descriptive-analytical study with cross-sectional method.","fulltext":[{"header":"Introductıon","content":"\u003cp\u003eFresh frozen plasma (FFP) is a blood component prepared by freezing plasma, obtained from either whole blood or apheresis, at a temperature and duration that allows plasma proteins, particularly clotting factors, to maintain their functions. It contains clotting factors, immunoglobulins, and albumin. FFP is generally transfused for two main indications: to prevent bleeding (prophylactic) and to treat bleeding (therapeutic) [1]. In the \"Model for Estimating Blood Supply and Demand for the Purpose of Determining the Need for Change in Blood Transfusion Centers\" study within the scope of the \"Technical Assistance for the Improvement of the Transfusion Management System in Turkey\" project carried out between 2019 and 2022, FFP was ranked second with a usage rate of 25% of all blood and blood components transfused in 2019 [2].\u003c/p\u003e\n\u003cp\u003eFFP is considered to be a 'high-risk' blood component in terms of its potential to cause transfusion reactions [3]. According to 2021 Serious Hazards of Transfusion (SHOT) data, there is one transfusion reaction accounted for 1 per 10,000 FFP transfusions [4]. Additionally, FFP is the most commonly misused or inappropriately indicated blood component [5]. This situation complicates FFP stock management, leads to unnecessary costs, and, most importantly, exposes patients to transfusion risks. Despite the presence of numerous guidelines on the clinical usage of blood components, a high rate of reports of inappropriate FFP usage is still reported in the literatüre [6].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn this study, our aim was to assess the appropriateness and rationalization of FFP use on a clinical basis at Gülhane Training and Research Hospital.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eThis study was carried out in accordance with the Gülhane Scientific Research Ethics Committee (2020-344). Authors declare that the study was conducted in accordance with the Declaration of Helsinki and followed the ethical standards of Türkiye\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted on patients who were hospitalized and received FFP transfusions as part of their treatment at Gülhane Training and Research Hospital between 01 September 2020 and 01 September 2021. A total of ten departments in which FFP was used most according to the previous year's data were included in this study. As all of the data on cardiovascular surgery were obtained from patients undergoing bypass surgery, these data were excluded from the study. Fifteen patient files from each department were screened retrospectively to achieve a sample size determined by power analysis.\u003c/p\u003e\n\u003cp\u003eDemographic data (age and sex), diagnoses, surgical interventions (if any), active bleeding sites, coagulation parameter test results (PT, aPTT, INR), co-morbidities, and clinical outcomes (discharged, exitus) were retrieved from the hospital software system and medical records.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFormation of the FFP Transfusion Evaluation Form\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;College of American Pathologists (CAP)/British Committee for Standards in Haematology\u0026nbsp;(BCSH) guidelines, and similar studies were used to classify the clinical use of FFP [7-11]. Accordingly, FFP indications were divided into three groups as follows: appropriate, inappropriate, and partially appropriate FFP usage. The FFP Transfusion Evaluation Form form has been developed with the scientific expertise of a hematologist and a pediatric hematologist. This form was completed by a physician from each clinic participating in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eContinuous variables (demographic data and laboratory findings) were presented with descriptive statistics (M-mean, SD-standard deviation, min-minimum, max-maximum). Categorical variables were shown as numbers and percentages. The chi-square statistic was used to show whether or not there is a relationship between two categorical variables. The Fisher's Exact test was employed to analyze 2x2 groups formed by categorical variables. The Student's t-test was applied for the analysis of groups formed by continuous variables. The \u003cem\u003ep\u003c/em\u003e value was accepted \u0026lt;0.05 for statistical significance.\u0026nbsp;The sample size was estimated based on data from the literature and conducted assuming a power (1 − \u003cem\u003eβ\u003c/em\u003e) of 0.80 and \u003cem\u003eα\u003c/em\u003e = 0.05 (6,11).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 500 patients were included in the study, of whom 239 (47.8%) were male and 261 (52.2%) were female. The mean age (min-max) for males was 50.8 years (1-94) and for females 53.1 years (2-98). Analysis of the appropriateness of FFP transfusions showed that of the 500 cases, 26.6% (133/500) had appropriate indications, while 72.6% (363/500) had inappropriate indications. The remaining 4 cases were part of a partially correct classification.\u0026nbsp;Among the inappropriate indications, the most commonly reported indications were the “Use of more than 1 unit of EC (excluding massive transfusion) follwing “pre-transfusion INR \u0026lt;1.5”, “Sepsis (Normal coagulation profile. Irrespective of bleeding stages)”, and “Pre- or post-transfusion INR \u0026gt; 1.5 and/or prolonged PT/aPTT and no bleeding or surgery/procedure”. “Peri-surgical bleeding and pre- or post-transfusion INR \u0026gt; 1.5 and /or prolonged PT/aPTT waas \u0026nbsp;the most common indications among the appropriate indications (Table 1).\u003c/p\u003e\n\u003cp\u003eUpon examination of FFP usage among clinics, it has been determined that the Department of Emergency Medicine is the most appropriate setting for FFP use at a rate of 50% usage. In contrast, the Department of Obstetrics and Gynecology demonstrated the highest level of inappropriate usage at a rate of 4% (Figure 1). A total of 367 patients had an underlying disease. The main underlying reasons diseases were The most common underlying diseases in those who used FFP inappropriately were gastrointestinal (GI) malignancies (53/367, %14), trauma (32/367, 9%), and hematological malignancies (29/367, 8%) (Figure 2). There were a total of 257 patients whose coagulation parameters were tested before and after the transfusion. In this group of patients, before FFP transfusion, aPTT and INR values (mean±SD) were 37±24 and 2.2±1.4, respectively, whereas after transfusion these values were 29.4±13.4 and 1.4±0.7, respectively. A statistically significant decrease was observed for both test parameters (p\u0026lt;0.01). Of these, only 50 cases had a post-operative INR below 1.5.\u003c/p\u003e\n\u003cp\u003eThe mortality rate was determined as 18.4% (408/500). This rate was found to be 21% (28/133) in patients where FFP was used appropriately, 17% (62/363) in patients where it was not used appropriately, and 50% (2/4) in partially appropriate usage cases. The statistical analysis did not show a significant difference in the rate of mortality between these three patient groups (p=0.157).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe inappropriate use of FFP not only leads to transfusion reactions but also causes significant stock management problems for blood centers. These are some of the key concerns around this topic. There have been numerous studies worldwide investigating the inappropriate use of FFP and the underlying reasons. In these studies, the rate of inappropriate use of FFP varies from 21.3% to 83% [3,12]. The wide range of this rate may be due to the guidelines used, clinics where the study was conducted, and possible variability in the number of patients. Considering the available data, it is possible to say that the 72.6% rate obtained in our study is relatively high. This high rate is an indication that precautions should be in place in our hospital with regard to this issue. In this context, we plan to first share the existing data of the clinics with them, then encourage the clinicians to use the existing guidelines through the training sessions that we will organize, and to monitor the issue closely with regular follow-ups.\u003c/p\u003e\n\u003cp\u003eDetermining the reasons for inappropriate use of FFP is very important in solving this problem. In the study by Tinmouth and colleagues, the most common (54.8%) indications leading to inappropriate use was “INR 1.1-1.5 before transfusion / normal PTT (and normal PTT after transfusion, if available). Irrespective of bleeding status or procedure status” [11]. Similarly, in the study by Lingegowda and colleagues, “surgical conditions in which the coagulation profile is normal or slightly elevated” (48%) are the most frequent indication for inappropriate use [6]. Reviewing the data from our study, it can be said that clinicians tend to add FFP transfusion to EC transfusion when there is no critical or massive bleeding. After having the study data, discussions with physicians working in the relevant clinics revealed that this indication is applied under the assumption that the severity of bleeding in patients with trauma or perioperative bleeding cannot be predicted in advance or INR results may poorly reflect the actual coagulation profile. So, it is considered that the purpose of FFP administration in addition to EC transfusion in patients without active bleeding is prophylaxis or prevention of the development of dilutional coagulopathy. The availability of viscoelastic tests in the operating room, which best reflects the patient's coagulation profile during surgery, could significantly reduce inappropriate usage for these patients.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThere are also findings in the literature regarding the clinic-based evaluation of FFP usage. In a study of obstetric patients by Puri and colleagues, the most common reason (33/40; 82.5%) for inappropriate use of FFP was severe anemia [12]. Obstetrics and gynecology stand out among clinics with the highest rate of inappropriate FFP requests in our study. When the data of these patients are examined, it is seen that FFP was used inappropriately in 36 patients during various obstetric and surgical procedures without the need for massive transfusion. The second most common cause of inappropriate use is the use of FFP as a volume expander, with 10 cases. The use of fresh frozen plasma is contraindicated if the blood volume can be adequately replaced with other volume expanders. The second clinic in which inappropriate use occurred most frequently was the Orthopedic and Traumatology. Among a total of 47 inappropriate use in this clinic, the most frequent indication is \"the patient receiving more than 1 unit of red blood cell concentrate without massive transfusion along with FFP\" accounting for 32 cases, followed by the indication of \"volume replacement\" with 13 cases. Particularly, in the detailed evaluation of the first indication, it was observed that INR values were measured before and after surgery in all patients, and only two cases had values above 1.5. FFP transfusion was performed in these patients to prevent the coagulation profile from being impaired by EC transfusion due to the risk of post-operative intramedullary hemorrhage, even though there was no evidence of active hemorrhage [Ö. Erşen, 2023, pers.com.]\u003c/p\u003e\n\u003cp\u003eOf the 32 cases of inappropriate FFP use detected in the hematology clinic, factor deficiency was identified in 9 cases. Particularly in this patient group, the possible reasons for inappropriate usage can be summarized as follows: patients with factor 8 or 9 levels below 1% have an indication for routine prophylaxis treatment, while patients with factor levels \u0026gt;1% have an indication for use of specific coagulation factors for prophylaxis before surgery or in the event of recurrent bleeding. Being aware of how to use your own available coagulation factors in the event of bleeding, and being able to reach the medical facilities where bleeding is well managed, will increase the use of specific coagulation factor products instead of FFP. In patients with hemophilia A or B with factor levels \u0026gt;5%, who do not require prophylactic treatment and do not have a significant bleeding diathesis, FFP is more often preferred for surgical prophylaxis or emergency treatment of bleeding. Especially for those patients, factors related to the use of FFP instead of specific factor concentrates include the unavailability of specific coagulation factors in many healthcare centers, the need for a prescription for the use of specific coagulation factors, the low level of knowledge about bleeding management in patients with mild hemophilia, and the easier accessibility of FFP in emergency situations.\u003c/p\u003e\n\u003cp\u003eEvaluating coagulation test parameters is an important factor for determining appropriate indications for FFP transfusion. Generally, a 1.1-1.5-fold increase in PT/INR and aPTT values is considered sufficient for FFP transfusion [13]. However, especially during the perioperative period, this increase in coagulation parameters may not always have clinical significance. The non-linear relationship between coagulation factor levels and test results could be attributed to the fact that even in normal individuals test results may show an increase. Additionally, it is important to note that these tests are designed to assess fibrin formation, not predict bleeding. Therefore, when evaluating FFP transfusion indications based on coagulation test results, caution should be exercised, and the overall clinical context should be taken into consideration [9, 10].A decrease in PT and INR of 0.2 and 1.9 seconds, respectively, before and after transfusion was observed in a series of 4635 patients studied by Stanworth et al.[1]. A statistically significant decrease of 0.1 seconds in INR and 1.4 seconds in aPTT was observed in the study by Sugiyama et al.[14]. In our study, there was a statistically significant decrease of 7.6 and 0.8 seconds in aPTT and INR values before and after transfusion, respectively. Although the guidelines used for this study consider the results of coagulation tests as limiting values or determinants for FFP transfusion, it is possible to observe a change in this approach in current studies or in newly published treatment guidelines. In the latest guidelines published by the Japanese Ministry of Health on this subject, it is stated that there is no need to perform coagulation tests before FFP transfusion [14]. Additionally, especially for perioperative bleeding or trauma patients, it is considered a more accurate approach to use viscoelastic tests to assess transfusion needs and determine the current coagulation profile.\u003c/p\u003e\n\u003cp\u003eMalignancy and trauma come to the fore when examining the diseases of the patients in whom FFP was used inappropriately in our study. In Sugiyama's study investigating inappropriate FFP usage, the top three underlying diseases were cardiovascular surgery cases, followed by gastrointestinal bleeding and colorectal cancers [14]. The results appear to be similar when considering that our study did not include cases of cardiovascular surgery. The prominence of gastrointestinal malignancies may be due to the fact that these patients are treated in different clinics such as medical oncology, general surgery, and gastroenterology.\u003c/p\u003e\n\u003cp\u003eThe mortality rate was 18% when all patients in the study were considered. In two different studies investigating FFP usage in emergency departments in our country, the mortality rates were found to be 7.2% and 6.4% [15, 16]. In a study conducted in Japan, this rate was reported as 16.2% [14]. In our study, there was no statistically significant difference in mortality between the groups of patients in whom FFP was used appropriately and those in whom it was not used. However, independent factors such as age, number of FFP units transfused, and high post-transfusion INR and PTT levels, which may influence mortality, should also be evaluated to accurately assess the relationship between FFP use and mortality.\u003c/p\u003e\n\u003cp\u003eThis study is subject to several limitations. The retrospective design should be considered in this context. Another limitation is the unavailability of coagulation test results for all patients.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eDespite the existence of numerous national/international guidelines on the use of FFP, it has been observed that clinicians do not follow these guidelines to the desired level. Furthermore, having guidelines to help guide the correct indications alone is not enough. There is an absolute need to develop new strategies that include continuous training and monitoring processes. Transfusion committees should play a more active role in the use of blood and blood components. To this end, internal audit mechanisms should be put in place and data relating to the use of FFP should be monitored on a regular basis. \u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgement:\u003c/strong\u003e We would like to thank medical doctors Mesudiye Bulut, Murat Yıldırım, Ulaş Fidan, Levent Yamanel, Musa Barış Aykan, Orhan Gürsel, Ömer Erşen, Harun Erdal, and Umut Kara for their contributions to the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest:\u003c/strong\u003e None declared.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial Disclosure:\u003c/strong\u003e The author declared that this study has received no financial support.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAuthor contribution:Concept: M.Y. and S.Y. and D.G.G. Design: M.Y. and S.Y. and D.G.G.Data Collection or Processing: E.S.Y. and S.K. and G.A. and I.Y.A.Analysis or Interpretation: S.K. and U.Y.Literature Search: S.K. and U.Y. and G.A.Writing: M.Y. and S.Y.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eStanworth SJ, Grant-Casey J, Lowe D, Laffan M, New H, Murphy MF, AllardS. The use of fresh-frozen plasma in England: high levels of inappropriate use in adults and children. Transfusion 2011;51(1), 62-70.\u003c/li\u003e\n\u003cli\u003eT.C. Sağlık Bakanlığı, T\u0026uuml;rkiye\u0026rsquo;de Kan Transf\u0026uuml;zyon Y\u0026ouml;netim Sisteminin Geliştirilmesi i\u0026ccedil;in Teknik Yardım Projesi , Kan Hizmet Birimlerinde Değişim İhtiya\u0026ccedil;larının Belirlenmesine Y\u0026ouml;nelik Kan Arz ve Talebi Tahmin Modeli Accessed 20 September 2023. https://hastakanyonetimi.saglik.gov.tr/Content/ListIndex/?id=1019\u003c/li\u003e\n\u003cli\u003ePahuja S, Sethi N, Singh S, Sharma S, Jain M, Kushwaha S. Concurrent audit of fresh frozen plasma: experience of a tertiary care hospital. Hematology 2012;17(5), 306-310.\u003c/li\u003e\n\u003cli\u003eS Narayan (Ed) D Poles et al. on behalf of the Serious Hazards of Transfusion (SHOT) Steering Group. The 2021 Annual SHOT Report (2022). \u003c/li\u003e\n\u003cli\u003eLanzoni M, Olivero B, Artoni A, Marconi M, Raspollini E, Castaldi S. Use of fresh-frozen plasma in 2012 at the Fondazione Ca\u0026apos; Granda Hospital of Milan: assessment of appropriateness using record linkage techniques applied to data routinely recorded in various hospital information systems. Blood Transfus. 2018;16(3):253-261.\u003c/li\u003e\n\u003cli\u003eLingegowda JB, Jeyakumar JD, Muddegowda PH, Pitchai R, Gopal N, Sinha P. An Audit of Requests for Fresh Frozen Plasma in a Tertiary Care Center in South India. J Lab Physicians. 2016;8(1):41-44.\u003c/li\u003e\n\u003cli\u003eKanın Uygun Klinik Kullanım Rehberi. Kan ve Kan \u0026Uuml;r\u0026uuml;nleri Dairesi Başkanlığı, Ankara 2020. Accessed 20 September 2023. https://dosyamerkez.saglik.gov.tr/Eklenti/37459/0/kanin-uygun-klinik-kullanimi-rehberi-kukk--23-mayis-2020pdf.pdf\u003c/li\u003e\n\u003cli\u003eLundberg GD. Guidelines P. Practice parameters for the use of fresh-frozen plasma. J Am Med Assoc. 1994;271(3).\u003c/li\u003e\n\u003cli\u003eBolton-Maggs P, Beattie C, Cardigan R, Kallis Y, Stanworth SJ, Green L. Corrigendum to British Society of Haematology Guidelines on the spectrum of fresh frozen plasma and cryoprecipitate products: their handling and use in various patient groups in the absence of major bleeding British. J Haematol. 2018;181(1):54e67.\u003c/li\u003e\n\u003cli\u003eWong MP, Droubatchevskaia N, Chipperfield KM, Wadsworth LD, Ferguson DJ. Guidelines for frozen plasma transfusion. B C Med J. 2007;49(6):311e319.\u003c/li\u003e\n\u003cli\u003eTinmouth A, Thompson T, Arnold DM, Callum JL, Gagliardi K, Lauzon D, Owens W, Pinkerton P. Utilization of frozen plasma in Ontario: a provincewide audit reveals a high rate of inappropriate transfusions. Transfusion 2013;53:2222\u0026ndash;9\u003c/li\u003e\n\u003cli\u003ePuri V, Dhal I, Singh K, Sharma G, Rai P, Sharma S. Critical audit of fresh frozen plasma transfusion practices in obstetric and gynecology departments in a tertiary care hospital\u0026ndash;Where and what needs to be improved? Glob J of Transf Med 2019; 4(2), 175.\u003c/li\u003e\n\u003cli\u003eKumar S, Kushwaha N, Tomar A, Philip J, Biswas AK. A retrospective audit to evaluate the appropriateness and rationalization of Fresh Frozen Plasma usage in a tertiary care hospital. Med J Armed Forces India 2022;78, S226-S231.\u003c/li\u003e\n\u003cli\u003eSugiyama A, Fujii T, Okikawa Y, Sasaki F, Okajima M, Hidaka H et al. Outcomes of patients who undergo transfusion of fresh frozen plasma: a prospective, observational, multicentre cohort study in Hiroshima, Japan. J Blood Med 2021; 965-973\u003c/li\u003e\n\u003cli\u003eEmektar E, Dagar S, Corbacioglu SK, Uzunosmanoglu H, Oncul MV, Cevik Y. The evaluation of the audit of Fresh-Frozen Plasma (FFP) usage in the emergency department. Turk J Emerg Med 2016;16(4), 137-140.\u003c/li\u003e\n\u003cli\u003eKaramurat M, Durak VA, K\u0026ouml;ksal \u0026Ouml;. Bir \u0026Uuml;niversite Hastanesi Acil Servisi\u0026apos;nde Taze Donmuş Plazma (TDP) Verilen Hastaların Retrospektif Analizi. Uludağ Tıp Derg. 2018; 44(3), 197-202.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1. \u0026nbsp;Classification of FFP trnasfusions\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFFP Transfusion Indications\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eN (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eInappropriate Indications\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eUse of more than 1 unit of EC (excluding massive transfusion). Pre-transfusion INR \u0026lt;1.5\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e136 (27.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eSepsis (Normal coagulation profile. Irrespective of bleeding stages)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e49 (9.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003ePre- or post-transfusion INR \u0026gt; 1.5 and/or prolonged PT/aPTT and no bleeding or surgery/procedure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e47 (9,4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003ePre-transfusion INR 1.1-1.5. Irrespective of bleeding status or procedure status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e45 (9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eVolume replacement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e32 (6.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eLiver disease pre- or post-transfusion INR \u0026gt; 1.5 and/or prolonged PT/aPTT and no bleeding or surgery/procedure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29 (6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eHemophilia A/B\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e12 (2.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eReversal of warfarin effect and no bleeding or going for an invasive procedure/surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10 (2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003ePre-paracentesis / Hypoalbuminemia\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3 (0.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eTotal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e363 (72.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eAppropriate Indications\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003ePeri-surgical bleeding and pre- or post-transfusion INR \u0026gt; 1.5 and /or prolonged PT/aPTT\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29 (5,8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eLiver disease (prolonged PT/aPTT or INR \u0026gt; 1.5) with bleeding or going for an invasive procedure/surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e19 (3.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eMassive transfusion and pre- or post-transfusion INR \u0026gt; 1.5 and/or prolonged PT/aPTT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e19 (3.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eDIC/Multiple coagulation factor deficiencies (INR \u0026gt; 1.5 and/or prolonged PT/aPTT) associated with bleeding or going for an invasive procedure/surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e18 (3.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eReversal of warfarin effect, only in cases of bleeding or prior to an invasive procedure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e23 (4,6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eInherited deficiencies of individual coagulation factors (factor XI, protein C, antithrombin III, etc.) for which there is no specific factor concentrate available\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15 (3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eThrombotic Thrombocytopenic Purpura\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e9 (1.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eHereditary Angioedema\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1 (0.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eTotal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003ePartial Correct Indication\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e133 (26.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003eNo laboratory coagulation data pre- or –post-transfusion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (0.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd\u003e\n \u003cp\u003e\u003cstrong\u003eTotal\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (0.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bratislava-medical-journal","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Bratislava Medical Journal](https://link.springer.com/journal/44411)","snPcode":"44411","submissionUrl":"https://submission.springernature.com/new-submission/44411/3","title":"Bratislava Medical Journal","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Fresh frozen plasma, transfusion, coagulation, mortality","lastPublishedDoi":"10.21203/rs.3.rs-5392902/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5392902/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective: \u003c/strong\u003eFresh frozen plasma (FFP) is a life-saving treatment agent when used correctly, but it is also the one which is the most inappropriately used among the blood components. The aim of this study is to evaluate FFP transfusion indications based on different clinics.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThe study was carried out with the data obtained as a result of retrospective reviewing of the data of a total of 500 patients from 10 different clinics. FFP Transfusion Evaluation Form was created after scanning national/international articles, guidelines, and similar publications regarding the use of FFP.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eIt was determined that FFP was used at a rate of 26.6 % within appropriate indications. In terms of mortality development, there was no difference between the indication groups (p=0,31). There was no difference between the indication groups in the number of cases in which INR decreased with FFP transfusion (p=0,14). While the mean aPTT levels decreased from 48,2±32,1 to 31±15,4 (p\u0026lt;0,01) after transfusion, the mean INR values decreased from 3,6±3,8 to 1,6±0,8 (p\u0026lt; 0,04).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eThe high rate of inappropriate use of FFP both threatens patient health due to transfusion reactions and affects stock management in blood centers adversely. The results obtained from the study reveal that standards and guidelines should be established for the appropriate use of FFP, both on a hospital and hospital basis, and the process should be audited at regular intervals in terms of ensuring clinicians' compliance with them and appropriate use.\u003c/p\u003e","manuscriptTitle":"“Assessment of the utilization of fresh frozen plasma in a training and research hospital: What does the high level of inappropriate use tell us?” A descriptive-analytical study with cross-sectional method.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-12-11 14:12:42","doi":"10.21203/rs.3.rs-5392902/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-01-12T08:32:59+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-12-30T07:37:03+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-12-20T17:13:09+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"152702828705222105645255897524188903863","date":"2024-12-15T13:30:18+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"6714305917732293746439851236392396856","date":"2024-12-10T13:06:20+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-12-10T11:56:33+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-11-08T13:44:13+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-11-08T13:38:30+00:00","index":"","fulltext":""},{"type":"submitted","content":"Bratislava Medical Journal","date":"2024-11-05T06:54:04+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bratislava-medical-journal","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [Bratislava Medical Journal](https://link.springer.com/journal/44411)","snPcode":"44411","submissionUrl":"https://submission.springernature.com/new-submission/44411/3","title":"Bratislava Medical Journal","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"8214cdc5-dd19-4718-ba6a-302a4567a109","owner":[],"postedDate":"December 11th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-05-19T09:53:15+00:00","versionOfRecord":[],"versionCreatedAt":"2024-12-11 14:12:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5392902","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5392902","identity":"rs-5392902","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}