A Cohort, Semi-Randomized, Open Label Quality Improvement Patient Blood Management (PBM) Comparison of Point of Care Viscoelastic Coagulation Monitors in Cardiac Surgery

A Cohort, Semi-Randomized, Open Label Quality Improvement Patient Blood Management (PBM) Comparison of Point of Care Viscoelastic Coagulation Monitors in Cardiac Surgery | 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 Cohort, Semi-Randomized, Open Label Quality Improvement Patient Blood Management (PBM) Comparison of Point of Care Viscoelastic Coagulation Monitors in Cardiac Surgery Bruce Spiess, Melissa Burger, Mary Jane Michael, Peter Pellitier, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4577712/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 Purpose: Viscoelastic testing (VET), recommended for heart surgery, has not been adopted due to lack of timely point of care (POC) technology. Several POC VET devices have become available. The purposes of this quality initiative (QI), part of a patient blood management program-PBM), were to: 1) Compare two POC VET for timeliness 2) Survey need, ease of use, acceptability, and set up for the on-going PBM program. Methods: The TEG-6s and the Quantra Q-plus Hemostasis Analyzer, were assessed in cardiac patients (n = 68) over a six-week period (May 15 -June 30, 2021). Timeliness of data acquisition was analyzed. Algorithms to assist physicians in therapeutic interventions were created. Cardiac members answered quality assessment surveys. Impacts on blood ordering were analyzed compared to a corresponding 6-week period pre COVID-19 epidemic. Results: Prior to the QI initiative, respondents noted time problems for laboratory coagulation analysis and acquisition of blood products. TEG 6s reporting time was 24.9 +/-4 minutes. Quantra Qplus required 49% less time, 12.9 +/- 1.3 minutes (P<0.0001). No differences in transfusion were seen. The use of POC VET reduced blood products ordered, unused, returned to the blood bank. Conclusions: We describe head-to-head testing prior to implementation as the next step in PBM QI. Quantra Qplus was twice as fast. Clinicians preferred the speed, ease of use, and interpretability of the Quantra. Large studies are needed to investigate the PBM benefit of POC VET. Coagulation Patient Blood Management Cardiac Surgery Bleeding Coagulopathy Hemorrhage Fresh Frozen Plasma Cryoprecipitate Platelet Concentrates Blood Bank Quality Assurance Sonorheometry Viscoelastic Testing VET PBM Thromboelastograph TEG6s Quantra Qplus Figures Figure 1 Figure 2 Figure 3 Introduction Patient blood management (PBM) is a patient centric discipline and quality initiative (QI) that improves outcomes, patient satisfaction and collaboration between caregiver teams. PBM reduces unnecessary transfusions, cuts costs and improves public health. , , , , ,6 The World Health Organization (WHO) called for countries to adopt PBM as a powerful QI. 1 The Joint Commission (TJC) has standards for PBM that may in future be metrics. 5 The three pillars of PBM are: 1) Diagnose and treat anemia; 2) Reduce peri-procedural blood loss, conserve red blood cells (RBCs), and manage coagulation dysfunction; and 3) Manage post-procedural anemia to optimize physiologic reserve as well as manage coagulation dysfunction. 1, ,7,8,9 Timely coagulation assessment with actionable data is part of the second and third pillars of PBM and is the “C” of the ABC’s (anemia bleeding and coagulation) of PBM. 1,7,8,9 Coagulation treatment without laboratory data is based on “clinical judgement,” is poor medicine, human error. 1–9 Unguided management of coagulopathy leads to ongoing blood loss, or thrombosis, excess transfusions, with adverse short-term and long-term outcomes. 1, , , , , , , , ,,16 Breakthroughs in POC VET allow clinicians to meet guidelines. RBC transfusions are associated with increased in-hospital death (13–16% /unit and additive) immunosuppression, increased length of ICU/hospital stay, renal insufficiency/failure, pneumonia, hospital-acquired infections, adult respiratory distress syndrome, transfusion-related acute lung injury (TRALI), transfusion associated cardiac overload (TACO), prolonged ventilation, and myocardial infarctions. 1,11–17,18,19, Unguided fresh frozen plasma (FFP) and platelet (Plt) transfusions are directly related to TRALI, stroke, and death (6–10% increased mortality/unit). 18–22 Unguided use of pro-coagulant pharmaceuticals create hypercoagulability, thrombosis and increased cost. 23 Variable blood usage in cardiac surgery persists. 21,22 Consensus guidelines for POC VET (level 1-B) have not been adopted. 23, 24,25,26 Wide QI is possible for cardiac care if PBM principles were to be standard. Efforts in Enhanced Recovery After Surgery (ERAs) stress PBM adoption. 27 Prolonged coagulation data acquisition from CLCA leads to frustrations and prevalence of “clinical judgement” therapy. Coagulation changes quickly at times, dynamically and needs to be assessed in real time. Prior VET (TEG), marketed as POC, was never bedside or quick. It most often was housed in central laboratories where trained staff provided quality control and reproducibility. CLCA or reductive testing that is non-VET: i.e., platelet count (PC), fibrinogen level (Fib), D-Dimer, prothrombin time (P)T, international normalized ratio-INR, activated Partial Thromboplastin time-(aPTT) has poor (< 50% predictive) predictive accuracy in bleeding cardiac patients. 28 VET, invented in 1947, evaluates whole blood shear modulus changing from liquid to gel. 29 Whole blood contains coagulation cells, proteinases with fibrinogen, and stabilizing factors interacting together as a system, minus in vivo flow dynamics, pressure shear, and live endothelium. For over 16 years, guidelines recommend timely, data-driven, coagulation-guided therapy utilizing POC VET. 2,23–26 Meta-analysis of laboratory-based VET studies found decreases in red blood, Plt, and FFP transfusions compared with CLCA, along with improved outcomes. 27,28,29,30,31,33,34,35,36 Thromboelastography (TEG, Haemonetics Inc., Braintree, Massachusetts, USA), Rotational Thromboelastometry (RoTEM; Werfen, Bedford, Massachusetts, USA), and viscometry (Sonoclot; Sienco Inc, Boulder, Colorado, USA), are marketed VET platforms from which the metanalyses were performed. 36 None have been universally adopted. Processing time for the TEG 5000 has been measured at 39–69 minutes and its use by untrained personnel or without quality controls run every day is not recommended. 37 Therefore, even if systems allowed its use in the OR the data might be outdated in a rapidly bleeding patient. Since TEG 5000 is usually housed in central laboratories (for quality control/regulatory reasons) data times reported do not include sample transport and clerical time. 37 “Clinical judgement” has occurred due to the monitoring time gap made up of poor CLCA reductionist prediction of bleeding and prolonged VET turnaround times. “Clinical judgement” is a best guess effort to treat bleeding in the vacuum of data. “Clinical judgement” is unguided, not individualized, not quality medicine, not PBM, introduces human error and is not patient specific. Failure to adopt the WHO call to action and clinical judgement is sub-standard medicine. 38 The utility of POC VET is now being evaluated. 39–44 The two monitors we examined correlate with predicate VETs (hence FDA approved marketing), have correlations with laboratory Fib, PC, and some platelet function testing. Our institution undertook a study evaluating two next generation POC VET devices, TEG 6s (Haemonetics Inc., Braintree, Massachusetts, USA) and Quantra Q plus Hemostasis Analyzer (HemoSonics Inc., Triangle Park, North Carolina, USA). These devices are designed for bedside OR usage to provide rapid, real time, functional whole blood coagulation data, while eliminating central laboratory time requirements. This was a multidisciplinary QI study in the OR with treatment algorithms with the intent of deciding for the hospital which system to deploy in PBM. We analyzed a comparison between the two devices in terms of turnaround time, central laboratory time to data acquisition, physicians’ surveys of impressions (ease of use and impact), and effects on the ordering, usage, and wastage of coagulation components. Methods The University of Florida Institutional Review Board (IRB) approved the QI project without a requirement of patient informed consent. Prior to the QI project commencing, PBM cardiac team-teaching discussions examined the complexity of coagulopathy to create a shared mental model, discussed the algorithms, and went over the QI project as a construct for PBM change. The discussions culminated with instruction (by company representatives) and proficiency of the anesthesia care team regarding the two POC VET devices. This QI was administered by laboratory medicine. The POC Division of Laboratory Medicine supervised training (along with the companies), deployment and data gathering. Laboratory medicine collaborated with QI anesthesiologists, and the project biostatistician to devise an evaluation schema (surveys) for the POC VET clinician needs and perceived improvements. Questionnaires (Table 1 – 2 ) were distributed electronically, which cardiac team physicians answered anonymously. A pretrial questionnaire (Table 1 ) focused on if there was a need for change, a desire to follow guidelines, and whether a PBM change might improve patient outcomes. The follow-up questionnaire (Table 2 ) was sent 2 weeks after the QI trial, focused upon ease of use, clinician preferences, and perceptions of whether by using these POC VET monitors patients would be better served. A randomization schema placed a single (TEG 6s or a Quantra Q-plus) machine in the four cardiac ORs. No OR had both technologies at any time. There is no way to blind such a study hence it was open label. This was not a randomized controlled trial but was structured as a cohort QI to see which system the physicians felt worked best to improve their patient care. The team was instructed to use the POC monitor and its algorithm for all cases (urgent/emergent included). Three ORs perform “on-pump” cardiopulmonary bypass (CPB) and one hybrid suite performs percutaneous valve deployments, or “overflow” CPB cases. Two operating rooms were randomly assigned a TEG6s or a Quantra Qplus system and the assignments were switched at three weeks so that each OR had experiences for an equal time. The evaluation was conducted for six weeks (May 15 - June 30, 2021). Treatment algorithms for the Quantra Q-plus (Fig. 1 ) and the TEG 6s (Fig. 2 ) were created based upon the limits of “normal” values. The team was encouraged to perform three or more POC VET: Pre-CPB, During CPB at the end of rewarming, 5 minutes after protamine administration, and if bleeding persisted. Samples were run only in the OR, not from the ICU. The team used CLCA at their discretion, including TEG 5000. Data was recorded electronically. After protamine and while the POC VET was being run, the surgical and anesthesiology attendings were asked to rate mediastinal bleeding from 0 to 5 (0 = dry to 5 = major bleeding). All ordered or administered coagulation products and pharmaceutical procoagulants were documented. Of particular importance was the length of “testing time,” defined as from blood draw until full data acquisition. Data time reported from the CLCA was the time from when the blood sample was drawn until the last ordered test results were reported on the electronic medical record (EMR). For retrospective comparison, data regarding blood utilization and ordering was examined from all cases during the same six-week period in 2019 (selected because it was prior to the COVID-19 pandemic) from the EMR. Data on the average amount of blood ordered, transfused, or unutilized/wasted was compared to the POC device group (together). For statistical analysis, the groups (TEG 6s vs Quantra Q-plus) were compared using chi-square or Wilcoxon rank sum two-sided tests using SAS Software version 9.4 (Cary, NC) with the level of significance set at P ≤ 0.05. Demographic data were reported as percent or mean where appropriate. Blood ordered, infused, and unused/wasted was reported as mean number of units and standard deviations of the mean (SD). Mean, standard deviations, as well as outliers for the two POC VET were calculated and displayed as whisker plots. Results Thirty-eight team members answered the pretrial survey (Table 1 ) (21 anesthesiologists, nine surgeons, and ten perfusionists). Eighty one percent felt extremely (56%) or moderately (25%) concerned regarding blood product utilizing and wastage. Sixty four percent were extremely (42%) or moderately (22%) familiar with blood product wastage in our ORs. The acceptability of wait time to receive results from laboratory testing was 3% acceptable, 14% slightly acceptable, 25% neutral, 22% slightly unacceptable, and 36% unacceptable. Acceptability of times to receive blood products were 8% acceptable, 17% slightly acceptable, 25% neutral, 42% slightly unacceptable, and 8% unacceptable. Data was collected on sixty-eight patients during the six weeks of POC VET testing. Thirty-seven patients were studied with the Quantra Q-plus and thirty-one using the TEG 6S. Surgery types and demographics of the two groups are reported in Table 2 . Twice as many complex aortic replacements were monitored with the Quantra Q-plus. This did not translate into a difference in either the coldest CPB temperature or the length of CPB. Our tertiary referral center performs complex cases (note the substantial number of major aortic replacements) and CPB times were long. The demographics of sex, age, length of surgery, and limited descriptors were not different between groups (Table 2 ). With POC technologies, the mean post-protamine micro bleed score assigned by the surgery team was low in both groups (1.1–1.5) and not different between groups (Table 3 ). Blood product transfusion was also not found to differ between the two POC VET (Table 4 ). The Quantra Q-plus returned results in mean (SD) time of 12.9 (1.3) min vs the TEG 6s with a mean (SD) time of 24.9 (4.0) min (p < 0.0001) (Fig. 1 ). The laboratory-based TEG 5000 device had a mean (SD) time of 75 (21) min for the TEG with Heparinase and 77 (21) min for a standard TEG. The post-trial questionnaire (Table 1 for the questions) concentrated on the anesthesia team only -those who would be performing the tests. Seventy-five percent felt that the POC testing improved PBM and 62.5% felt that it improved patient care. One hundred percent felt that the Quantra Q-plus was either easy (37.5%) or quite easy (62.5%) to use; 75% felt that the TEG 6s was easy (37.5%) or very easy to use (37.5%), with 25% neutral toward whether TEG 6s was easy or not. No one felt that either test was difficult to use. The Quantra Q-plus had a major (25%), moderate (62.5%), or no (12.5%) effect on the administration of blood products while respondents reported that TEG 6s had a moderate (37.5%), neutral (37.5%), minor (12.5%), or no (12.5%) effect. When surveying on Quantra Q-plus algorithm (Fig. 2 ) and ease of interpretation, 25% strongly agreed, 50% agreed, 12.5% neither agreed or disagreed, and 12.5% disagreed that the algorithm helped in decision-making. When surveying on TEG 6s, 50% agreed, 25% neither agreed nor disagreed, and 25% disagreed that the algorithm (Fig. 4) and ease of interpretation helped in decision-making for patient care. A limited retrospective analysis of blood product ordering, transfusion, and waste was performed comparing the POC group to a control group of all adult cardiac surgery patients from the same six-week calendar period in the year 2019. Overall, in the control group (2019 data) excess ordering (unused or wasted) of 1.13 units of blood per case, occurred compared to an average of 0.22 units per case in the POC group (p < 0.0001), a reduction of 81% in unused/wasted components (Table 4 ). The control group unused/wasted an average of 0.71 units of FFP per case compared to 0.06 units of FFP per case in the POC group, a reduction of 91% (p < 0.0001) The control group wasted an average of 0.22 units of platelets per case compared to 0.04 units of platelets per case in the POC group, a reduction of 82% (p = 0.0104). The control group wasted an average of 0.20 units of cryoprecipitate per case compared to 0.13 units of cryoprecipitate per case in the POC group but was not found to be significantly different (p = 0.2230). Discussion Effective coagulation PBM requires rapid acquisition of individualized patient data before ordering blood products. In this PBM QI initiative, we evaluated real-time POC VET in the cardiac surgery operating room with two new generation viscoelastic testing technologies. Time to actionable coagulation data from standard laboratory testing has created a lack of VET utilization and non-conformance with guidelines. POC VET is the answer to allow cardiac teams to make PBM coagulation decisions as a part of patient care. Both tests were much quicker than awaiting central laboratory VET. Substantial differences in the length of time required for data acquisition was found between the two tested POC VET. The Quantra Q-plus was twice as fast with a mean (SD) of 12.9 (1.3) minutes vs TEG 6s with a mean (SD) of 24.9 (4.0) min (p < 0.0001). Time to first actionable data was not evaluated because all VET parameters are interdependent due to biologic complexity of inflammation and coagulation. Also, there are no published standards for “first actionable data” so we could not define that as a parameter. The algorithms required the team to consider all parameters, not just one. The algorithms were developed in consultation with the equipment companies, based on published normal values (reported on file to the FDA). No coagulation should be administered, prophylactically, without the presence of microvascular bleeding. Our data assessing severity of bleeding showed that little microvascular bleeding occurred in this cohort of patients. Future research using POC VET could utilize these bleeding scores to help to decide whether any coagulation products are required. For example, if the microvascular bleeding score is below some cutoff point (yet to be determined), is it more prudent to watch, wait and retest with a fast POC VET rather than to utilize a coagulation product that is costly, in short supply and associated with adverse outcomes? This is speculative but by having POC VET one could make evidence-based decisions with future research. Prophylactic treatment with coagulation products, even if supported by VET data, does not make sense if the patient is clotting. Further research is needed to determine the best cutoff values, as the coagulation milieu is markedly different from a population of healthy volunteers. For example, if two parameters are within normal range but at the low ends is it possible those two parameters might lead a patient to bleeding after CPB? We do not know that from our small QI project and more research is required. During the time prior to POC evaluating 1.68 times the amount of coagulation products was ordered than was administered (Table 4 ). We believe this behavior was due to empiric ordering to circumvent wait time frustration occurring from laboratory-based results. During the POC test period, the teams ordered only 1.12 times what was transfused (p < 0.0001). This demonstrates the impact of POC VET upon human behavior. Transfusion is a human behavior, one that should be driven by data. When coagulation data was rapidly available, the teams ordered only what was needed. The dramatic 91% reduction in unutilized/waste of FFP and 82% reduction in waste of platelets would be expected to lead to cost savings, but that was not assessed in this small study (n = 68). Reduction in cryoprecipitate waste did not reach statistical significance, due to small sample size. In cost analysis models, laboratory-based VET is cost effective compared to standard laboratory testing alone owing to the direct cost savings from reduced transfusions as well as indirect savings due to reduction in transfusion related complications and associated hospital costs and length of stay. In this QI initiative, we demonstrated significant reduction in blood product wastage with POC VET. We plan to further analyze cost analysis models at our institution in a larger study. Both the TEG 6s and Quantra Q-plus have been studied comparing their parameters to older generation VET, such as ROTEM and TEG 5000, and to evaluate inter-device concordance. 39–44 . Our QI study is unique. It was focused on PBM, and asked providers what they perceived as problems as well as which technology would best support their ability to care for patients. Technology, to effect change, must be user friendly; one way to assess that is to simply ask the users if the technology assisted their decision-making. Furthermore, time to actionable coagulation data is important. Another study has compared POC VET and Quantra was the fastest in that study as well. 45 Our study showed similar findings but focused upon the fact that to make complete coagulation algorithm decisions all data, not “first actionable”/incomplete data. We find our study unique in its demonstration of changes in human behavior regarding ordering unutilized products. The prophylactic ordering of expensive and scarce blood resources, taking them out of the blood bank, and making them unavailable to other patients is an underappreciated problem. We suspect that the lay public does not know of the problem of wastage of their altruistically donated blood. Cardiac teams practice “clinical judgement” ordering of blood products to do a “work around” for lack of monitoring technology. Now with POC VET that behavior cannot be accepted. We did not compare blood usage between POC VET to only standard laboratory testing such as CBC, fibrinogen, as our institution already had a higher standard of care involving laboratory-based VET. Multiple systematic reviews and metanalyses of laboratory-based VET vs. clinical judgment or standard laboratory testing in cardiac surgery patients have demonstrated reduction in FFP, platelets, and red blood cell transfusions. ,28–36 We would expect the newer generation POC VET to further enhance such an advantage, but that requires a different study than ours. A limitation of our study is the small sample size (n = 68). This study reported here was not a trial of POC and overall reduction of blood usage, bleeding, outcomes, and costs. Also, this was a single centered study and the answers to the survey questions might well differ in other medical centers. We do think the use of the survey for those wishing to implement enhanced PBM QI in coagulation might be helpful and we encourage centers to use these questions to construct their own programs. We do not believe there was any source of bias, because the clinicians were asked their opinions in a blinded anonymous fashion although some bias in terms of reducing wastage occurred due to a “Hawthorn effect.” Thus, once the technology has settled into routine practice then further analysis of changes in blood product usage and outcomes could be more meaningful. Another limitation is that practices might have changed between the times compared. One was pre-COVID-19, and the other was during resolution of the pandemic. We plan to further analyze the impact of these devices on our transfusion practices across a much larger group of patients once they are deployed in ORs for some time. Our surveys represent the opinion of a small group of people, but they represent the opinions of over 75% of users of the technology. Rather, they are presented to illustrate the desire for timely data and evidence-based guidance in transfusion practices among clinicians. They serve as a description of how our institution successfully implemented POC coagulation monitoring as a part of the PBM program. Providing transfusion algorithms and real time data utilizing POC devices allowed multidisciplinary teams to agree on best transfusion practices resulting in significant decrease in wastage of blood components and very quick time appropriate decisions. Additional research is needed to fully evaluate the impact on cost savings, potential reduction in transfusion, and improvement in patient outcomes that may result from implementing point of care coagulation monitoring devices in operating rooms. Conclusion VET has been shown to reduce unnecessary, unguided or “clinical judgement” blood component transfusions compared to standard laboratory testing. Adoption of new rapid POC VET reduced clinical guesswork and empiric therapies, resulting in decreased blood product ordering without usage (waste). Further research is needed to establish if the newer generation devices can further reduce unnecessary blood transfusions and procoagulant drug administration compared to legacy devices. Hospitals are encouraged to adopt POC VET coagulation management systems to comply with guidelines, to advance PBM, and to share clinical pathways to improve the care of patients undergoing cardiac surgery. Declarations Competing Interests Bruce D. Spiess, MD is Medical Director for HemoSonics, LLC. He was not in that position at the time of the study.No others have any potential conflicts. Author Contribution A: BDS, MB, MJM, SG, CG, PP, MZ- conceived of and carried out the study.B: BDS, CG, MJM- analyzed the dataC: BDS, MB, CG- prepared the primary manuscriptD: BDS, MB, MJM, SG, PP, MZ- reviewed and edited the manuscriptE: BDS, CG MJM-created the Tables and Figures Data Availability Data is supplied wihtin the mansucript and kept on file at the University of Florida References World Health Organization. The urgent need to implement patient blood management: policy brief. 2021; ISBN-978-92-4-003574-4. Hohmuth B, Ozawa S, Ashton M, Melseth RL. Patient-centered blood management. J Hosp Med . 2014;9(1):60-65. doi:10.1002/jhm.2116 Desai N, Schofield N, Richards T. Perioperative Patient Blood Management to Improve Outcomes. Anesth Analg . 2018;127(5):1211-1220. doi:10.1213/ANE.0000000000002549 Hofmann A, Farmer S, Shander A. Five drivers shifting the paradigm from product-focused transfusion practice to patient blood management. Oncologist . 2011;16 Suppl 3:3-11. doi:10.1634/theoncologist.2011-S3-3 Gammon HM, Waters JH, Watt A, Loeb JM, Donini-Lenhoff A. Developing performance measures for patient blood management. Transfusion . 2011;51(11):2500-2509. doi:10.1111/j.1537-2995.2011.03406. Shander A, Hardy JF, Ozawa S, et al. A global definition of patient blood management. Anesth Analg 2022; 135: 476-488. Althoff FC, Neb H, Herrmann E, et al. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. Ann Surg . 2019;269(5):794-804. doi:10.1097/SLA.0000000000003095 Hofmann A, Shander A, Blumberg N, Hamdorf JM, Isbister JP, Gross I. Patient blood management: Improving outcomes for million while saving billions. What is holding us up? Anesth Analg 2022; 135: 511-523. Valentine SL, Chollette, Goobie SM. Transfusion strategies for hemostatic blood products in critically ill children: A narrative review and update on expert consensus guidelines. Anesth Analg 2022; 135: 545-557. Leahy MF, Hofmann A, Towler S, et al. Improved outcomes and reduced costs associated with a health-system-wide patient blood management program: a retrospective observational study in four major adult tertiary-care hospitals. Transfusion . 2017;57(6):1347-1358. doi:10.1111/trf.14006 Freedman J. The ONTraC Ontario program in blood conservation. Transfus Apher Sci . 2014;50(1):32-36. doi: 10.1016/j.transci.2013.12.010 Spiess BD. Transfusion and outcome in heart surgery. Ann Thorac Surg . 2002;74(4):986-987. doi:10.1016/s0003-4975(02)03906-1 Crescenzi G, Torracca L, Capestro F, Matteucci ML, Rossi M. Allogenic blood transfusion in cardiac surgery. J Card Surg . 2012;27(5):594-599. doi:10.1111/j.1540-8191.2012. 01522.x Paone G, Likosky DS, Brewer R, et al. Transfusion of 1 and 2 units of red blood cells is associated with increased morbidity and mortality. Ann Thorac Surg . 2014;97(1):87-94. doi: 10.1016/j.athoracsur.2013.07.020 Horvath KA, Acker MA, Chang H, et al. Blood transfusion and infection after cardiac surgery. Ann Thorac Surg . 2013;95(6):2194-2201. doi: 10.1016/j.athoracsur.2012.11.078 LaPar DJ, Hawkins RB, McMurry TL, et al. Preoperative anemia versus blood transfusion: Which is the culprit for worse outcomes in cardiac surgery? J Thorac Cardiovasc Surg . 2018;156(1):66-74. e2. doi: 10.1016/j.jtcvs.2018.03.109 Vlot EA, Verwijmeren L, van de Garde EMW, Kloppenburg GTL, van Dongen EPA, Noordzij PG. Intra-operative red blood cell transfusion and mortality after cardiac surgery. BMC Anesthesiol . 2019;19(1):65. Published 2019 May 4. doi:10.1186/s12871-019-0738-2 Ad N, Massimiano PS, Rongione A, et. al. Number and type of blood products are negatively associated with outcomes after cardiac surgery. Annals Thorac Surg 2022; 113: 748-56. Maclennan S, Williamson LM. Risks of fresh frozen plasma and platelets. J Trauma 2006; 60 (6 suppl): S46-S60. Doi: 10.1097/01.ta.0000199546.22925.31. Koch C, LiL, Figueroa P, Mihaljevic T, Svensson L, Blackstone EH. Transfusion and pulmonary morbidity after cardiac surgery. Ann Thorac Surg 2009; 88 (5); 1410-1418. Doi:10: 10.1016/j.athoracsur.2009.07.020. Spiess BD. A little coagulation knowledge can be dangerous! Can j Anaesth 2009; 56: 478-482. Doi:10.1007/s12630-009-9107-9. Spiess, BD, Royston D, Levy JH, Fitch, Dietrich W, Body S, Murkin J, Nadel A. Platelet transfusions during coronary artery bypass graft surgery are associated with serious adverse outcomes . T ransfusion 2004; 44:1143-8. : Society of Thoracic Surgeons Blood Conservation Task Force, Ferraris VA, Brown Jr et al. 2011 update to the Society of Thoracic Surgeons and Society of Cardiovascular Anesthesiologists blood conservation and clinical practice guideline. Ann Thorac surg 2011;91 (3) 944-982. Doi10.1016/j.athoracsurg.2010.11.078. American Society of Anesthesiologists Task Force on Perioperative Practice Guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists. Anesthesiology 2015;122 (2):241-275. Raphael J, Mazer CD, Subramani S, Schroeder A, Abdalla M, Ferreira R, Roman PE, Patel N, Welsby I, Greilich PE, Harvey R, Ranucci M, Heller LB, Boer C, Wilkey A, Hill SE, Nuttall GA, Palvadi RR, Patel PA, Wilkey B, Gaitan B, Hill SS, Kwak J, Klick J, Bollen BA, Shore-Lesserson L, Abernathy J, Schwann N, Lau WT. Society of Cardiovascular Anesthesiologists Clinical Practice Improvement Advisory for Management of Perioperative Bleeding and Hemostasis in Cardiac Surgery Patients. Anesth Analg. 2019 Nov;129(5):1209-1221. Klein A, Agarwal S, Cholley B, et. al. A review of European guidelines for patient blood management with a particular emphasis on antifibrinolytic drug administration during cardiac surgery. J Clin Anesth 2022;78: 110654; doi: 10.1016/j.jclinans.2022.110654. Guinn NR, Goobie SM. Patient blood management: The forgotten element of enhanced recovery after surgery programs. Anesth Analg 2022; 135: 474-475. Welsby IJ, Jiao K, Ortel TL, et al. The kaolin activated thromboelastograph predicts bleeding after cardiac surgery. JCTVA 2006;20: 531-535. Whiting P, Al M, Westwood M, et al. Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis. Health Technol Assess . 2015;19(58):1-vi. doi:10.3310/hta19580 Serraino GF, Murphy GJ. Routine use of viscoelastic blood tests for diagnosis and treatment of coagulopathic bleeding in cardiac surgery: updated systematic review and meta-analysis. Br J Anaesth . 2017;118(6):823-833. doi:10.1093/bja/aex100 WikkelsøA, Wettenslev J, Møller AM, Afshari A. Thromboelastography (TEG) or Thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database System Rev 2016; Aug 22; 2016 (8): CD 00781.doi: 10.1002/14651858.CD007871.pub3. Teodoro L, Nascimento B, Rizoli S. Thromboelastography (TEG): practical considerations on its clinical use in trauma resuscitation. Scan J Trauma Resus EM 2013;29: doi.org/10.1186/1757-7241-21-29. Goobie SM. Patient blood management is a new standard of care to optimize blood health. Anesth Analg 2022; 135:443-446. Baryshnikova E, DiDedda U, Ranucci M. A comparative study of SEER Sonorheometry versus standard coagulation tests rotational thromboelastometry and multiple electrode aggregometry in cardiac surgery. JCTVA 2019; 33 (6): 1590-1598. Huffmyer JL, Fernandez LG, Haghighian C, et. al. Comparison of SEER Sonorheometry with rotational thromboelastometry and laboratory parameters in cardiac surgery. Anesth Analg 2016; 123 (6): 1390-1399.doi:10.1213/ANE.00000000001507. Sniecinski RM, Tanaka KA, SEER Sonorheometry: listening to what the clot has to say. Anesth Analg 2016; 123: 1346-1347. Reynolds PS, Middelton P, McCarthy H, Spiess BD. A comparison of a new ultrasound based whole blood viscoelastic teste (SEER Sonorheometry) versus thromboelastography in cardiac surgery. Anesth Analg 2016; 123 (6) 1400-1407. Volod O, Bunch CM, Zackariya, et. al. Viscoelastic hemostatic assays: a primer on legacy and new generation devices. J Clin Med 2022;11 (3) 860. Doi 10.3390/jcm11030860. Viola F, Kramer MD, Lawrence MB, Oberhauser JP, Walker WF. Sonorheometry: a noncontact method for the dynamic assessment of thrombosis. Ann Biomed Eng 2004; 32 (5) 696-705. Doi:10.1023/b: abme.0000030235. 72255.df. PMID.1517162. Bauliq W, Akbar S, Schütt PK, et. al. Comparison of the resonance sonorheometry based Quantra system with rotational thromboelastometry (ROTEM) sigma in cardiac surgery: a prospective observational study. BMC Anesthesiology 2021; 21: 260. Doi.org/10.1186/s12871-021-01469-5. Tables Tables 1 to 4 are available in the Supplementary Files section. Additional Declarations Competing interest reported. Bruce D. Spiess, MD is Medical Director for HemoSonics, LLC. He was not in that position at the time of the study. No others have any potential conflicts. Supplementary Files Tables.docx Cite Share Download PDF Status: Posted Version 1 posted 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-4577712","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":317787438,"identity":"9c82f22b-5078-4c2f-81e4-bfb3e0fb4ec6","order_by":0,"name":"Bruce Spiess","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIiWNgGAWjYBACe/4DDAeAtBxMgJ8PSEjg02I4IwGsxRjMA7Ik2whpMbgBoRMbiNZiOIP34IEPf+rS+2c3H/78geGwBBsD88HbPHj9ci7h4My2w7kz7hxLkzgA1sKWbI1Pi2FDjsFh3oYDuQ03csyADjtcx8bAYyaNT4vBAaCWP0CHyd/I//wBYgv/N8JaGNiYEwxu5DBAHcbDhleL4Yy8hIO9bYcNN95IM5M4Y5AuwcbMZmw5B6/3zx7+8ONPnbzcjeTHHyoqrCX42Zsf3niDRwsDA4obDICYGa9yDC2jYBSMglEwCrAAAKCkTsqtMEk3AAAAAElFTkSuQmCC","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Bruce","middleName":"","lastName":"Spiess","suffix":""},{"id":317787439,"identity":"d91d27c3-dda5-42ae-b72a-5d2c7a189d73","order_by":1,"name":"Melissa Burger","email":"","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Melissa","middleName":"","lastName":"Burger","suffix":""},{"id":317787440,"identity":"9fa9aea6-f58e-431b-a252-e24cf470d517","order_by":2,"name":"Mary Jane Michael","email":"","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Mary","middleName":"Jane","lastName":"Michael","suffix":""},{"id":317787441,"identity":"384e9919-79cb-4056-b299-a67585a055c9","order_by":3,"name":"Peter Pellitier","email":"","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Peter","middleName":"","lastName":"Pellitier","suffix":""},{"id":317787442,"identity":"290fcaf7-4399-43ad-88ed-121c018cfa13","order_by":4,"name":"Cynthia Garvan","email":"","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Cynthia","middleName":"","lastName":"Garvan","suffix":""},{"id":317787443,"identity":"58e9d74a-3230-4738-b343-a8dc207fe203","order_by":5,"name":"Marc Zumberg","email":"","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Marc","middleName":"","lastName":"Zumberg","suffix":""},{"id":317787444,"identity":"a947e33d-147e-46d6-a6ce-b5356e15584a","order_by":6,"name":"Stephanie Gore","email":"","orcid":"","institution":"University of Florida School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Stephanie","middleName":"","lastName":"Gore","suffix":""}],"badges":[],"createdAt":"2024-06-13 17:21:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4577712/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4577712/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":60200324,"identity":"e057d080-65f1-47e2-8f97-63ab29a0492b","added_by":"auto","created_at":"2024-07-13 02:32:41","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":179138,"visible":true,"origin":"","legend":"\u003cp\u003eThe algorithm utilized for treatment decisions by the team for the Quantra Qplus results.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4577712/v1/392b43d5b062e3439d6dff35.jpg"},{"id":60200321,"identity":"e1d6a588-02cc-45f2-9365-d44a4a258964","added_by":"auto","created_at":"2024-07-13 02:32:41","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":95874,"visible":true,"origin":"","legend":"\u003cp\u003eThe algorithm used for the TEG 6-S regarding decisions utilized by the team.\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4577712/v1/b77ec31dd67265834a188029.jpg"},{"id":60200322,"identity":"28d72a1d-1038-4c39-ae26-e7fba812ebe2","added_by":"auto","created_at":"2024-07-13 02:32:41","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":38383,"visible":true,"origin":"","legend":"\u003cp\u003eWisker plots, mean 1 and 2 SD form the mean and outliers for time to data acquisition from when blood was drawn until all coagulation data was available. Quantra- Qplus mean 12.9 minutes (1.3 SD) and for TEG6s 24.9 minutes (4.0 SD), P \u0026lt;0.0001.\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4577712/v1/5b51ec5138408e04182b5020.jpg"},{"id":76551147,"identity":"8aab05f0-16d6-4888-b4fd-fddb2053a498","added_by":"auto","created_at":"2025-02-18 10:02:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":762452,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4577712/v1/e8942e1c-4344-437c-84b6-3ab6d38b3b2d.pdf"},{"id":60200323,"identity":"862d1fbe-e718-42ac-be63-f06cd2bc71d4","added_by":"auto","created_at":"2024-07-13 02:32:41","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":32175,"visible":true,"origin":"","legend":"","description":"","filename":"Tables.docx","url":"https://assets-eu.researchsquare.com/files/rs-4577712/v1/213a2ba6bada3b24e3cd6b73.docx"}],"financialInterests":"Competing interest reported. Bruce D. Spiess, MD is Medical Director for HemoSonics, LLC. He was not in that position at the time of the study.\nNo others have any potential conflicts.","formattedTitle":"A Cohort, Semi-Randomized, Open Label Quality Improvement Patient Blood Management (PBM) Comparison of Point of Care Viscoelastic Coagulation Monitors in Cardiac Surgery","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePatient blood management (PBM) is a patient centric discipline and quality initiative (QI) that improves outcomes, patient satisfaction and collaboration between caregiver teams. PBM reduces unnecessary transfusions, cuts costs and improves public health.\u003ca class=\"FNLink\" href=\"#Fn1\" id=\"#FNLinkFn1\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn2\" id=\"#FNLinkFn2\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn3\" id=\"#FNLinkFn3\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn4\" id=\"#FNLinkFn4\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn5\" id=\"#FNLinkFn5\"\u003e\u003c/a\u003e\u003csup\u003e,6\u003c/sup\u003e The World Health Organization (WHO) called for countries to adopt PBM as a powerful QI.\u003csup\u003e1\u003c/sup\u003e The Joint Commission (TJC) has standards for PBM that may in future be metrics.\u003csup\u003e5\u003c/sup\u003e The three pillars of PBM are: 1) Diagnose and treat anemia; 2) Reduce peri-procedural blood loss, conserve red blood cells (RBCs), and manage coagulation dysfunction; and 3) Manage post-procedural anemia to optimize physiologic reserve as well as manage coagulation dysfunction.\u003csup\u003e1,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn6\" id=\"#FNLinkFn6\"\u003e\u003c/a\u003e\u003csup\u003e,7,8,9\u003c/sup\u003e Timely coagulation assessment with actionable data is part of the second and third pillars of PBM and is the \u0026ldquo;C\u0026rdquo; of the ABC\u0026rsquo;s (anemia bleeding and coagulation) of PBM.\u003csup\u003e1,7,8,9\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eCoagulation treatment without laboratory data is based on \u0026ldquo;clinical judgement,\u0026rdquo; is poor medicine, human error.\u003csup\u003e1\u0026ndash;9\u003c/sup\u003e Unguided management of coagulopathy leads to ongoing blood loss, or thrombosis, excess transfusions, with adverse short-term and long-term outcomes. \u003csup\u003e1,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn7\" id=\"#FNLinkFn7\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn8\" id=\"#FNLinkFn8\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn9\" id=\"#FNLinkFn9\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn10\" id=\"#FNLinkFn10\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn11\" id=\"#FNLinkFn11\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn12\" id=\"#FNLinkFn12\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn13\" id=\"#FNLinkFn13\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn14\" id=\"#FNLinkFn14\"\u003e\u003c/a\u003e\u003csup\u003e,,16\u003c/sup\u003e Breakthroughs in POC VET allow clinicians to meet guidelines.\u003c/p\u003e \u003cp\u003eRBC transfusions are associated with increased in-hospital death (13\u0026ndash;16% /unit and additive) immunosuppression, increased length of ICU/hospital stay, renal insufficiency/failure, pneumonia, hospital-acquired infections, adult respiratory distress syndrome, transfusion-related acute lung injury (TRALI), transfusion associated cardiac overload (TACO), prolonged ventilation, and myocardial infarctions.\u003csup\u003e1,11\u0026ndash;17,18,19,\u003c/sup\u003e Unguided fresh frozen plasma (FFP) and platelet (Plt) transfusions are directly related to TRALI, stroke, and death (6\u0026ndash;10% increased mortality/unit).\u003csup\u003e18\u0026ndash;22\u003c/sup\u003e Unguided use of pro-coagulant pharmaceuticals create hypercoagulability, thrombosis and increased cost.\u003csup\u003e23\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eVariable blood usage in cardiac surgery persists.\u003csup\u003e21,22\u003c/sup\u003e Consensus guidelines for POC VET (level 1-B) have not been adopted.\u003csup\u003e23, 24,25,26\u003c/sup\u003e Wide QI is possible for cardiac care if PBM principles were to be standard. Efforts in Enhanced Recovery After Surgery (ERAs) stress PBM adoption.\u003csup\u003e27\u003c/sup\u003e Prolonged coagulation data acquisition from CLCA leads to frustrations and prevalence of \u0026ldquo;clinical judgement\u0026rdquo; therapy. Coagulation changes quickly at times, dynamically and needs to be assessed in real time.\u003c/p\u003e \u003cp\u003ePrior VET (TEG), marketed as POC, was never bedside or quick. It most often was housed in central laboratories where trained staff provided quality control and reproducibility. CLCA or reductive testing that is non-VET: i.e., platelet count (PC), fibrinogen level (Fib), D-Dimer, prothrombin time (P)T, international normalized ratio-INR, activated Partial Thromboplastin time-(aPTT) has poor (\u0026lt;\u0026thinsp;50% predictive) predictive accuracy in bleeding cardiac patients. \u003csup\u003e28\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eVET, invented in 1947, evaluates whole blood shear modulus changing from liquid to gel.\u003csup\u003e29\u003c/sup\u003e Whole blood contains coagulation cells, proteinases with fibrinogen, and stabilizing factors interacting together as a system, minus in vivo flow dynamics, pressure shear, and live endothelium. For over 16 years, guidelines recommend timely, data-driven, coagulation-guided therapy utilizing POC VET.\u003csup\u003e2,23\u0026ndash;26\u003c/sup\u003e Meta-analysis of laboratory-based VET studies found decreases in red blood, Plt, and FFP transfusions compared with CLCA, along with improved outcomes. \u003csup\u003e27,28,29,30,31,33,34,35,36\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThromboelastography (TEG, Haemonetics Inc., Braintree, Massachusetts, USA), Rotational Thromboelastometry (RoTEM; Werfen, Bedford, Massachusetts, USA), and viscometry (Sonoclot; Sienco Inc, Boulder, Colorado, USA), are marketed VET platforms from which the metanalyses were performed.\u003csup\u003e36\u003c/sup\u003e None have been universally adopted.\u003c/p\u003e \u003cp\u003eProcessing time for the TEG 5000 has been measured at 39\u0026ndash;69 minutes and its use by untrained personnel or without quality controls run every day is not recommended.\u003csup\u003e37\u003c/sup\u003e Therefore, even if systems allowed its use in the OR the data might be outdated in a rapidly bleeding patient. Since TEG 5000 is usually housed in central laboratories (for quality control/regulatory reasons) data times reported do not include sample transport and clerical time.\u003csup\u003e37\u003c/sup\u003e \u0026ldquo;Clinical judgement\u0026rdquo; has occurred due to the monitoring time gap made up of poor CLCA reductionist prediction of bleeding and prolonged VET turnaround times.\u003c/p\u003e \u003cp\u003e\u0026ldquo;Clinical judgement\u0026rdquo; is a best guess effort to treat bleeding in the vacuum of data. \u0026ldquo;Clinical judgement\u0026rdquo; is unguided, not individualized, not quality medicine, not PBM, introduces human error and is not patient specific. Failure to adopt the WHO call to action and clinical judgement is sub-standard medicine.\u003csup\u003e38\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe utility of POC VET is now being evaluated.\u003csup\u003e39\u0026ndash;44\u003c/sup\u003e The two monitors we examined correlate with predicate VETs (hence FDA approved marketing), have correlations with laboratory Fib, PC, and some platelet function testing. Our institution undertook a study evaluating two next generation POC VET devices, TEG 6s (Haemonetics Inc., Braintree, Massachusetts, USA) and Quantra Q plus Hemostasis Analyzer (HemoSonics Inc., Triangle Park, North Carolina, USA). These devices are designed for bedside OR usage to provide rapid, real time, functional whole blood coagulation data, while eliminating central laboratory time requirements.\u003c/p\u003e \u003cp\u003eThis was a multidisciplinary QI study in the OR with treatment algorithms with the intent of deciding for the hospital which system to deploy in PBM. We analyzed a comparison between the two devices in terms of turnaround time, central laboratory time to data acquisition, physicians\u0026rsquo; surveys of impressions (ease of use and impact), and effects on the ordering, usage, and wastage of coagulation components.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe University of Florida Institutional Review Board (IRB) approved the QI project without a requirement of patient informed consent. Prior to the QI project commencing, PBM cardiac team-teaching discussions examined the complexity of coagulopathy to create a shared mental model, discussed the algorithms, and went over the QI project as a construct for PBM change. The discussions culminated with instruction (by company representatives) and proficiency of the anesthesia care team regarding the two POC VET devices.\u003c/p\u003e \u003cp\u003eThis QI was administered by laboratory medicine. The POC Division of Laboratory Medicine supervised training (along with the companies), deployment and data gathering. Laboratory medicine collaborated with QI anesthesiologists, and the project biostatistician to devise an evaluation schema (surveys) for the POC VET clinician needs and perceived improvements.\u003c/p\u003e \u003cp\u003eQuestionnaires (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) were distributed electronically, which cardiac team physicians answered anonymously. A pretrial questionnaire (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) focused on if there was a need for change, a desire to follow guidelines, and whether a PBM change might improve patient outcomes. The follow-up questionnaire (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) was sent 2 weeks after the QI trial, focused upon ease of use, clinician preferences, and perceptions of whether by using these POC VET monitors patients would be better served.\u003c/p\u003e \u003cp\u003eA randomization schema placed a single (TEG 6s or a Quantra Q-plus) machine in the four cardiac ORs. No OR had both technologies at any time. There is no way to blind such a study hence it was open label. This was not a randomized controlled trial but was structured as a cohort QI to see which system the physicians felt worked best to improve their patient care.\u003c/p\u003e \u003cp\u003eThe team was instructed to use the POC monitor and its algorithm for all cases (urgent/emergent included). Three ORs perform \u0026ldquo;on-pump\u0026rdquo; cardiopulmonary bypass (CPB) and one hybrid suite performs percutaneous valve deployments, or \u0026ldquo;overflow\u0026rdquo; CPB cases. Two operating rooms were randomly assigned a TEG6s or a Quantra Qplus system and the assignments were switched at three weeks so that each OR had experiences for an equal time. The evaluation was conducted for six weeks (May 15 - June 30, 2021).\u003c/p\u003e \u003cp\u003eTreatment algorithms for the Quantra Q-plus (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) and the TEG 6s (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) were created based upon the limits of \u0026ldquo;normal\u0026rdquo; values. The team was encouraged to perform three or more POC VET: Pre-CPB, During CPB at the end of rewarming, 5 minutes after protamine administration, and if bleeding persisted. Samples were run only in the OR, not from the ICU. The team used CLCA at their discretion, including TEG 5000.\u003c/p\u003e \u003cp\u003eData was recorded electronically. After protamine and while the POC VET was being run, the surgical and anesthesiology attendings were asked to rate mediastinal bleeding from 0 to 5 (0\u0026thinsp;=\u0026thinsp;dry to 5\u0026thinsp;=\u0026thinsp;major bleeding). All ordered or administered coagulation products and pharmaceutical procoagulants were documented. Of particular importance was the length of \u0026ldquo;testing time,\u0026rdquo; defined as from blood draw until full data acquisition. Data time reported from the CLCA was the time from when the blood sample was drawn until the last ordered test results were reported on the electronic medical record (EMR).\u003c/p\u003e \u003cp\u003eFor retrospective comparison, data regarding blood utilization and ordering was examined from all cases during the same six-week period in 2019 (selected because it was prior to the COVID-19 pandemic) from the EMR. Data on the average amount of blood ordered, transfused, or unutilized/wasted was compared to the POC device group (together).\u003c/p\u003e \u003cp\u003eFor statistical analysis, the groups (TEG 6s vs Quantra Q-plus) were compared using chi-square or Wilcoxon rank sum two-sided tests using SAS Software version 9.4 (Cary, NC) with the level of significance set at P\u0026thinsp;\u0026le;\u0026thinsp;0.05. Demographic data were reported as percent or mean where appropriate. Blood ordered, infused, and unused/wasted was reported as mean number of units and standard deviations of the mean (SD). Mean, standard deviations, as well as outliers for the two POC VET were calculated and displayed as whisker plots.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThirty-eight team members answered the pretrial survey (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) (21 anesthesiologists, nine surgeons, and ten perfusionists). Eighty one percent felt extremely (56%) or moderately (25%) concerned regarding blood product utilizing and wastage. Sixty four percent were extremely (42%) or moderately (22%) familiar with blood product wastage in our ORs. The acceptability of wait time to receive results from laboratory testing was 3% acceptable, 14% slightly acceptable, 25% neutral, 22% slightly unacceptable, and 36% unacceptable. Acceptability of times to receive blood products were 8% acceptable, 17% slightly acceptable, 25% neutral, 42% slightly unacceptable, and 8% unacceptable.\u003c/p\u003e \u003cp\u003eData was collected on sixty-eight patients during the six weeks of POC VET testing. Thirty-seven patients were studied with the Quantra Q-plus and thirty-one using the TEG 6S. Surgery types and demographics of the two groups are reported in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Twice as many complex aortic replacements were monitored with the Quantra Q-plus. This did not translate into a difference in either the coldest CPB temperature or the length of CPB. Our tertiary referral center performs complex cases (note the substantial number of major aortic replacements) and CPB times were long. The demographics of sex, age, length of surgery, and limited descriptors were not different between groups (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). With POC technologies, the mean post-protamine micro bleed score assigned by the surgery team was low in both groups (1.1\u0026ndash;1.5) and not different between groups (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Blood product transfusion was also not found to differ between the two POC VET (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe Quantra Q-plus returned results in mean (SD) time of 12.9 (1.3) min vs the TEG 6s with a mean (SD) time of 24.9 (4.0) min (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The laboratory-based TEG 5000 device had a mean (SD) time of 75 (21) min for the TEG with Heparinase and 77 (21) min for a standard TEG.\u003c/p\u003e \u003cp\u003eThe post-trial questionnaire (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e for the questions) concentrated on the anesthesia team only -those who would be performing the tests. Seventy-five percent felt that the POC testing improved PBM and 62.5% felt that it improved patient care. One hundred percent felt that the Quantra Q-plus was either easy (37.5%) or quite easy (62.5%) to use; 75% felt that the TEG 6s was easy (37.5%) or very easy to use (37.5%), with 25% neutral toward whether TEG 6s was easy or not. No one felt that either test was difficult to use. The Quantra Q-plus had a major (25%), moderate (62.5%), or no (12.5%) effect on the administration of blood products while respondents reported that TEG 6s had a moderate (37.5%), neutral (37.5%), minor (12.5%), or no (12.5%) effect. When surveying on Quantra Q-plus algorithm (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) and ease of interpretation, 25% strongly agreed, 50% agreed, 12.5% neither agreed or disagreed, and 12.5% disagreed that the algorithm helped in decision-making. When surveying on TEG 6s, 50% agreed, 25% neither agreed nor disagreed, and 25% disagreed that the algorithm (Fig.\u0026nbsp;4) and ease of interpretation helped in decision-making for patient care.\u003c/p\u003e \u003cp\u003eA limited retrospective analysis of blood product ordering, transfusion, and waste was performed comparing the POC group to a control group of all adult cardiac surgery patients from the same six-week calendar period in the year 2019. Overall, in the control group (2019 data) excess ordering (unused or wasted) of 1.13 units of blood per case, occurred compared to an average of 0.22 units per case in the POC group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), a reduction of 81% in unused/wasted components (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). The control group unused/wasted an average of 0.71 units of FFP per case compared to 0.06 units of FFP per case in the POC group, a reduction of 91% (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) The control group wasted an average of 0.22 units of platelets per case compared to 0.04 units of platelets per case in the POC group, a reduction of 82% (p\u0026thinsp;=\u0026thinsp;0.0104). The control group wasted an average of 0.20 units of cryoprecipitate per case compared to 0.13 units of cryoprecipitate per case in the POC group but was not found to be significantly different (p\u0026thinsp;=\u0026thinsp;0.2230).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eEffective coagulation PBM requires rapid acquisition of individualized patient data before ordering blood products. In this PBM QI initiative, we evaluated real-time POC VET in the cardiac surgery operating room with two new generation viscoelastic testing technologies. Time to actionable coagulation data from standard laboratory testing has created a lack of VET utilization and non-conformance with guidelines. POC VET is the answer to allow cardiac teams to make PBM coagulation decisions as a part of patient care. Both tests were much quicker than awaiting central laboratory VET.\u003c/p\u003e \u003cp\u003eSubstantial differences in the length of time required for data acquisition was found between the two tested POC VET. The Quantra Q-plus was twice as fast with a mean (SD) of 12.9 (1.3) minutes vs TEG 6s with a mean (SD) of 24.9 (4.0) min (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). Time to first actionable data was not evaluated because all VET parameters are interdependent due to biologic complexity of inflammation and coagulation. Also, there are no published standards for \u0026ldquo;first actionable data\u0026rdquo; so we could not define that as a parameter. The algorithms required the team to consider all parameters, not just one.\u003c/p\u003e \u003cp\u003eThe algorithms were developed in consultation with the equipment companies, based on published normal values (reported on file to the FDA). No coagulation should be administered, prophylactically, without the presence of microvascular bleeding. Our data assessing severity of bleeding showed that little microvascular bleeding occurred in this cohort of patients. Future research using POC VET could utilize these bleeding scores to help to decide whether any coagulation products are required. For example, if the microvascular bleeding score is below some cutoff point (yet to be determined), is it more prudent to watch, wait and retest with a fast POC VET rather than to utilize a coagulation product that is costly, in short supply and associated with adverse outcomes? This is speculative but by having POC VET one could make evidence-based decisions with future research.\u003c/p\u003e \u003cp\u003eProphylactic treatment with coagulation products, even if supported by VET data, does not make sense if the patient is clotting. Further research is needed to determine the best cutoff values, as the coagulation milieu is markedly different from a population of healthy volunteers. For example, if two parameters are within normal range but at the low ends is it possible those two parameters might lead a patient to bleeding after CPB? We do not know that from our small QI project and more research is required.\u003c/p\u003e \u003cp\u003eDuring the time prior to POC evaluating 1.68 times the amount of coagulation products was ordered than was administered (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). We believe this behavior was due to empiric ordering to circumvent wait time frustration occurring from laboratory-based results. During the POC test period, the teams ordered only 1.12 times what was transfused (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). This demonstrates the impact of POC VET upon human behavior. Transfusion is a human behavior, one that should be driven by data. When coagulation data was rapidly available, the teams ordered only what was needed. The dramatic 91% reduction in unutilized/waste of FFP and 82% reduction in waste of platelets would be expected to lead to cost savings, but that was not assessed in this small study (n\u0026thinsp;=\u0026thinsp;68). Reduction in cryoprecipitate waste did not reach statistical significance, due to small sample size. In cost analysis models, laboratory-based VET is cost effective compared to standard laboratory testing alone owing to the direct cost savings from reduced transfusions as well as indirect savings due to reduction in transfusion related complications and associated hospital costs and length of stay.\u003ca class=\"FNLink\" href=\"#Fn15\" id=\"#FNLinkFn15\"\u003e\u003c/a\u003e In this QI initiative, we demonstrated significant reduction in blood product wastage with POC VET. We plan to further analyze cost analysis models at our institution in a larger study. Both the TEG 6s and Quantra Q-plus have been studied comparing their parameters to older generation VET, such as ROTEM and TEG 5000, and to evaluate inter-device concordance.\u003csup\u003e39\u0026ndash;44\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eOur QI study is unique. It was focused on PBM, and asked providers what they perceived as problems as well as which technology would best support their ability to care for patients. Technology, to effect change, must be user friendly; one way to assess that is to simply ask the users if the technology assisted their decision-making. Furthermore, time to actionable coagulation data is important. Another study has compared POC VET and Quantra was the fastest in that study as well.\u003csup\u003e45\u003c/sup\u003e Our study showed similar findings but focused upon the fact that to make complete coagulation algorithm decisions all data, not \u0026ldquo;first actionable\u0026rdquo;/incomplete data.\u003c/p\u003e \u003cp\u003eWe find our study unique in its demonstration of changes in human behavior regarding ordering unutilized products. The prophylactic ordering of expensive and scarce blood resources, taking them out of the blood bank, and making them unavailable to other patients is an underappreciated problem. We suspect that the lay public does not know of the problem of wastage of their altruistically donated blood. Cardiac teams practice \u0026ldquo;clinical judgement\u0026rdquo; ordering of blood products to do a \u0026ldquo;work around\u0026rdquo; for lack of monitoring technology. Now with POC VET that behavior cannot be accepted.\u003c/p\u003e \u003cp\u003eWe did not compare blood usage between POC VET to only standard laboratory testing such as CBC, fibrinogen, as our institution already had a higher standard of care involving laboratory-based VET. Multiple systematic reviews and metanalyses of laboratory-based VET vs. clinical judgment or standard laboratory testing in cardiac surgery patients have demonstrated reduction in FFP, platelets, and red blood cell transfusions.\u003ca class=\"FNLink\" href=\"#Fn16\" id=\"#FNLinkFn16\"\u003e\u003c/a\u003e\u003csup\u003e,28\u0026ndash;36\u003c/sup\u003e We would expect the newer generation POC VET to further enhance such an advantage, but that requires a different study than ours.\u003c/p\u003e \u003cp\u003eA limitation of our study is the small sample size (n\u0026thinsp;=\u0026thinsp;68). This study reported here was not a trial of POC and overall reduction of blood usage, bleeding, outcomes, and costs. Also, this was a single centered study and the answers to the survey questions might well differ in other medical centers. We do think the use of the survey for those wishing to implement enhanced PBM QI in coagulation might be helpful and we encourage centers to use these questions to construct their own programs. We do not believe there was any source of bias, because the clinicians were asked their opinions in a blinded anonymous fashion although some bias in terms of reducing wastage occurred due to a \u0026ldquo;Hawthorn effect.\u0026rdquo; Thus, once the technology has settled into routine practice then further analysis of changes in blood product usage and outcomes could be more meaningful. Another limitation is that practices might have changed between the times compared. One was pre-COVID-19, and the other was during resolution of the pandemic.\u003c/p\u003e \u003cp\u003eWe plan to further analyze the impact of these devices on our transfusion practices across a much larger group of patients once they are deployed in ORs for some time. Our surveys represent the opinion of a small group of people, but they represent the opinions of over 75% of users of the technology. Rather, they are presented to illustrate the desire for timely data and evidence-based guidance in transfusion practices among clinicians. They serve as a description of how our institution successfully implemented POC coagulation monitoring as a part of the PBM program. Providing transfusion algorithms and real time data utilizing POC devices allowed multidisciplinary teams to agree on best transfusion practices resulting in significant decrease in wastage of blood components and very quick time appropriate decisions.\u003c/p\u003e \u003cp\u003eAdditional research is needed to fully evaluate the impact on cost savings, potential reduction in transfusion, and improvement in patient outcomes that may result from implementing point of care coagulation monitoring devices in operating rooms.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eVET has been shown to reduce unnecessary, unguided or \u0026ldquo;clinical judgement\u0026rdquo; blood component transfusions compared to standard laboratory testing. Adoption of new rapid POC VET reduced clinical guesswork and empiric therapies, resulting in decreased blood product ordering without usage (waste). Further research is needed to establish if the newer generation devices can further reduce unnecessary blood transfusions and procoagulant drug administration compared to legacy devices. Hospitals are encouraged to adopt POC VET coagulation management systems to comply with guidelines, to advance PBM, and to share clinical pathways to improve the care of patients undergoing cardiac surgery.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003cp\u003eBruce D. Spiess, MD is Medical Director for HemoSonics, LLC. He was not in that position at the time of the study.No others have any potential conflicts.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eA: BDS, MB, MJM, SG, CG, PP, MZ- conceived of and carried out the study.B: BDS, CG, MJM- analyzed the dataC: BDS, MB, CG- prepared the primary manuscriptD: BDS, MB, MJM, SG, PP, MZ- reviewed and edited the manuscriptE: BDS, CG MJM-created the Tables and Figures\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eData is supplied wihtin the mansucript and kept on file at the University of Florida\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organization. The urgent need to implement patient blood management: policy brief. 2021; ISBN-978-92-4-003574-4.\u003c/li\u003e\n\u003cli\u003eHohmuth B, Ozawa S, Ashton M, Melseth RL. Patient-centered blood management. \u003cem\u003eJ Hosp Med\u003c/em\u003e. 2014;9(1):60-65. doi:10.1002/jhm.2116\u003c/li\u003e\n\u003cli\u003eDesai N, Schofield N, Richards T. Perioperative Patient Blood Management to Improve Outcomes. \u003cem\u003eAnesth Analg\u003c/em\u003e. 2018;127(5):1211-1220. doi:10.1213/ANE.0000000000002549\u003c/li\u003e\n\u003cli\u003eHofmann A, Farmer S, Shander A. Five drivers shifting the paradigm from product-focused transfusion practice to patient blood management. \u003cem\u003eOncologist\u003c/em\u003e. 2011;16 Suppl 3:3-11. doi:10.1634/theoncologist.2011-S3-3\u003c/li\u003e\n\u003cli\u003eGammon HM, Waters JH, Watt A, Loeb JM, Donini-Lenhoff A. Developing performance measures for patient blood management. \u003cem\u003eTransfusion\u003c/em\u003e. 2011;51(11):2500-2509. doi:10.1111/j.1537-2995.2011.03406.\u003c/li\u003e\n\u003cli\u003eShander A, Hardy JF, Ozawa S, et al. A global definition of patient blood management. Anesth Analg 2022; 135: 476-488. \u003c/li\u003e\n\u003cli\u003eAlthoff FC, Neb H, Herrmann E, et al. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. \u003cem\u003eAnn Surg\u003c/em\u003e. 2019;269(5):794-804. doi:10.1097/SLA.0000000000003095\u003c/li\u003e\n\u003cli\u003eHofmann A, Shander A, Blumberg N, Hamdorf JM, Isbister JP, Gross I. Patient blood management: Improving outcomes for million while saving billions. What is holding us up? Anesth Analg 2022; 135: 511-523.\u003c/li\u003e\n\u003cli\u003eValentine SL, Chollette, Goobie SM. Transfusion strategies for hemostatic blood products in critically ill children: A narrative review and update on expert consensus guidelines. Anesth Analg 2022; 135: 545-557.\u003c/li\u003e\n\u003cli\u003eLeahy MF, Hofmann A, Towler S, et al. Improved outcomes and reduced costs associated with a health-system-wide patient blood management program: a retrospective observational study in four major adult tertiary-care hospitals. \u003cem\u003eTransfusion\u003c/em\u003e. 2017;57(6):1347-1358. doi:10.1111/trf.14006\u003c/li\u003e\n\u003cli\u003eFreedman J. The ONTraC Ontario program in blood conservation. \u003cem\u003eTransfus Apher Sci\u003c/em\u003e. 2014;50(1):32-36. doi: 10.1016/j.transci.2013.12.010\u003c/li\u003e\n\u003cli\u003eSpiess BD. Transfusion and outcome in heart surgery. \u003cem\u003eAnn Thorac Surg\u003c/em\u003e. 2002;74(4):986-987. doi:10.1016/s0003-4975(02)03906-1\u003c/li\u003e\n\u003cli\u003eCrescenzi G, Torracca L, Capestro F, Matteucci ML, Rossi M. Allogenic blood transfusion in cardiac surgery. \u003cem\u003eJ Card Surg\u003c/em\u003e. 2012;27(5):594-599. doi:10.1111/j.1540-8191.2012. 01522.x\u003c/li\u003e\n\u003cli\u003ePaone G, Likosky DS, Brewer R, et al. Transfusion of 1 and 2 units of red blood cells is associated with increased morbidity and mortality. \u003cem\u003eAnn Thorac Surg\u003c/em\u003e. 2014;97(1):87-94. doi: 10.1016/j.athoracsur.2013.07.020\u003c/li\u003e\n\u003cli\u003eHorvath KA, Acker MA, Chang H, et al. Blood transfusion and infection after cardiac surgery. \u003cem\u003eAnn Thorac Surg\u003c/em\u003e. 2013;95(6):2194-2201. doi: 10.1016/j.athoracsur.2012.11.078\u003c/li\u003e\n\u003cli\u003eLaPar DJ, Hawkins RB, McMurry TL, et al. Preoperative anemia versus blood transfusion: Which is the culprit for worse outcomes in cardiac surgery? \u003cem\u003eJ Thorac Cardiovasc Surg\u003c/em\u003e. 2018;156(1):66-74. e2. doi: 10.1016/j.jtcvs.2018.03.109\u003c/li\u003e\n\u003cli\u003eVlot EA, Verwijmeren L, van de Garde EMW, Kloppenburg GTL, van Dongen EPA, Noordzij PG. Intra-operative red blood cell transfusion and mortality after cardiac surgery. \u003cem\u003eBMC Anesthesiol\u003c/em\u003e. 2019;19(1):65. Published 2019 May 4. doi:10.1186/s12871-019-0738-2\u003c/li\u003e\n\u003cli\u003eAd N, Massimiano PS, Rongione A, et. al. Number and type of blood products are negatively associated with outcomes after cardiac surgery. Annals Thorac Surg 2022; 113: 748-56.\u003c/li\u003e\n\u003cli\u003eMaclennan S, Williamson LM. Risks of fresh frozen plasma and platelets. J Trauma 2006; 60 (6 suppl): S46-S60. Doi: 10.1097/01.ta.0000199546.22925.31.\u003c/li\u003e\n\u003cli\u003eKoch C, LiL, Figueroa P, Mihaljevic T, Svensson L, Blackstone EH. Transfusion and pulmonary morbidity after cardiac surgery. Ann Thorac Surg 2009; 88 (5); 1410-1418. Doi:10: 10.1016/j.athoracsur.2009.07.020.\u003c/li\u003e\n\u003cli\u003eSpiess BD. A little coagulation knowledge can be dangerous! Can j Anaesth 2009; 56: 478-482. Doi:10.1007/s12630-009-9107-9.\u003c/li\u003e\n\u003cli\u003eSpiess, BD, Royston D, Levy JH, Fitch, Dietrich W, Body S, Murkin J, Nadel A. Platelet transfusions during coronary artery bypass graft surgery are associated with serious adverse outcomes\u003cem\u003e.\u003c/em\u003e T\u003cem\u003eransfusion \u003c/em\u003e2004; 44:1143-8.\u003c/li\u003e\n\u003cli\u003e: Society of Thoracic Surgeons Blood Conservation Task Force, Ferraris VA, Brown Jr et al. 2011 update to the Society of Thoracic Surgeons and Society of Cardiovascular Anesthesiologists blood conservation and clinical practice guideline. Ann Thorac surg 2011;91 (3) 944-982. Doi10.1016/j.athoracsurg.2010.11.078.\u003c/li\u003e\n\u003cli\u003eAmerican Society of Anesthesiologists Task Force on Perioperative Practice Guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists. Anesthesiology 2015;122 (2):241-275.\u003c/li\u003e\n\u003cli\u003eRaphael J, Mazer CD, Subramani S, Schroeder A, Abdalla M, Ferreira R, Roman PE, Patel N, Welsby I, Greilich PE, Harvey R, Ranucci M, Heller LB, Boer C, Wilkey A, Hill SE, Nuttall GA, Palvadi RR, Patel PA, Wilkey B, Gaitan B, Hill SS, Kwak J, Klick J, Bollen BA, Shore-Lesserson L, Abernathy J, Schwann N, Lau WT. Society of Cardiovascular Anesthesiologists Clinical Practice Improvement Advisory for Management of Perioperative Bleeding and Hemostasis in Cardiac Surgery Patients. Anesth Analg. 2019 Nov;129(5):1209-1221.\u003c/li\u003e\n\u003cli\u003eKlein A, Agarwal S, Cholley B, et. al. A review of European guidelines for patient blood management with a particular emphasis on antifibrinolytic drug administration during cardiac surgery. J Clin Anesth 2022;78: 110654; doi: 10.1016/j.jclinans.2022.110654. \u003c/li\u003e\n\u003cli\u003eGuinn NR, Goobie SM. Patient blood management: The forgotten element of enhanced recovery after surgery programs. Anesth Analg 2022; 135: 474-475.\u003c/li\u003e\n\u003cli\u003eWelsby IJ, Jiao K, Ortel TL, et al. The kaolin activated thromboelastograph predicts bleeding after cardiac surgery. JCTVA 2006;20: 531-535.\u003c/li\u003e\n\u003cli\u003eWhiting P, Al M, Westwood M, et al. Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis. \u003cem\u003eHealth Technol Assess\u003c/em\u003e. 2015;19(58):1-vi. doi:10.3310/hta19580\u003c/li\u003e\n\u003cli\u003eSerraino GF, Murphy GJ. Routine use of viscoelastic blood tests for diagnosis and treatment of coagulopathic bleeding in cardiac surgery: updated systematic review and meta-analysis. \u003cem\u003eBr J Anaesth\u003c/em\u003e. 2017;118(6):823-833. doi:10.1093/bja/aex100\u003c/li\u003e\n\u003cli\u003eWikkels\u0026oslash;A, Wettenslev J, M\u0026oslash;ller AM, Afshari A. Thromboelastography (TEG) or Thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database System Rev 2016; Aug 22; 2016 (8): CD 00781.doi: 10.1002/14651858.CD007871.pub3.\u003c/li\u003e\n\u003cli\u003eTeodoro L, Nascimento B, Rizoli S. Thromboelastography (TEG): practical considerations on its clinical use in trauma resuscitation. Scan J Trauma Resus EM 2013;29: doi.org/10.1186/1757-7241-21-29.\u003c/li\u003e\n\u003cli\u003eGoobie SM. Patient blood management is a new standard of care to optimize blood health. Anesth Analg 2022; 135:443-446.\u003c/li\u003e\n\u003cli\u003eBaryshnikova E, DiDedda U, Ranucci M. A comparative study of SEER Sonorheometry versus standard coagulation tests rotational thromboelastometry and multiple electrode aggregometry in cardiac surgery. JCTVA 2019; 33 (6): 1590-1598.\u003c/li\u003e\n\u003cli\u003eHuffmyer JL, Fernandez LG, Haghighian C, et. al. Comparison of SEER Sonorheometry with rotational thromboelastometry and laboratory parameters in cardiac surgery. Anesth Analg 2016; 123 (6): 1390-1399.doi:10.1213/ANE.00000000001507.\u003c/li\u003e\n\u003cli\u003eSniecinski RM, Tanaka KA, SEER Sonorheometry: listening to what the clot has to say. Anesth Analg 2016; 123: 1346-1347.\u003c/li\u003e\n\u003cli\u003eReynolds PS, Middelton P, McCarthy H, Spiess BD. A comparison of a new ultrasound based whole blood viscoelastic teste (SEER Sonorheometry) versus thromboelastography in cardiac surgery. Anesth Analg 2016; 123 (6) 1400-1407.\u003c/li\u003e\n\u003cli\u003eVolod O, Bunch CM, Zackariya, et. al. Viscoelastic hemostatic assays: a primer on legacy and new generation devices. J Clin Med 2022;11 (3) 860. Doi 10.3390/jcm11030860.\u003c/li\u003e\n\u003cli\u003eViola F, Kramer MD, Lawrence MB, Oberhauser JP, Walker WF. Sonorheometry: a noncontact method for the dynamic assessment of thrombosis. Ann Biomed Eng 2004; 32 (5) 696-705. Doi:10.1023/b: abme.0000030235. 72255.df. PMID.1517162.\u003c/li\u003e\n\u003cli\u003eBauliq W, Akbar S, Sch\u0026uuml;tt PK, et. al. Comparison of the resonance sonorheometry based Quantra system with rotational thromboelastometry (ROTEM) sigma in cardiac surgery: a prospective observational study. BMC Anesthesiology 2021; 21: 260. Doi.org/10.1186/s12871-021-01469-5.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 4 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","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":"Coagulation, Patient Blood Management, Cardiac Surgery, Bleeding, Coagulopathy, Hemorrhage, Fresh Frozen Plasma, Cryoprecipitate, Platelet Concentrates, Blood Bank, Quality Assurance, Sonorheometry, Viscoelastic Testing, VET, PBM, Thromboelastograph, TEG6s, Quantra Qplus","lastPublishedDoi":"10.21203/rs.3.rs-4577712/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4577712/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose: \u003c/strong\u003eViscoelastic testing (VET), recommended for heart surgery, has not been adopted due to lack of timely point of care (POC) technology. Several POC VET devices have become available. \u0026nbsp;The purposes of this quality initiative (QI), part of a patient blood management program-PBM), were to: 1) Compare two POC VET for timeliness 2) Survey need, ease of use, acceptability, and set up for the on-going PBM program.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThe TEG-6s and the Quantra Q-plus Hemostasis Analyzer, were assessed in cardiac patients (n = 68) over a six-week period (May 15 -June 30, 2021). Timeliness of data acquisition was analyzed. Algorithms to assist physicians in therapeutic interventions were created. Cardiac members answered quality assessment surveys. Impacts on blood ordering were analyzed compared to a corresponding 6-week period pre COVID-19 epidemic.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Prior to the QI initiative, respondents noted time problems for laboratory coagulation analysis and acquisition of blood products. TEG 6s reporting time was 24.9 +/-4 minutes. Quantra Qplus required 49% less time, 12.9 +/- 1.3 minutes (P\u0026lt;0.0001). No differences in transfusion were seen. The use of POC VET reduced blood products ordered, unused, returned to the blood bank.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eWe describe head-to-head testing prior to implementation as the next step in PBM QI. Quantra Qplus was twice as fast. Clinicians preferred the speed, ease of use, and interpretability of the Quantra. Large studies are needed to investigate the PBM benefit of POC VET.\u003c/p\u003e","manuscriptTitle":"A Cohort, Semi-Randomized, Open Label Quality Improvement Patient Blood Management (PBM) Comparison of Point of Care Viscoelastic Coagulation Monitors in Cardiac Surgery","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-13 02:32:36","doi":"10.21203/rs.3.rs-4577712/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":"c7bc248f-adba-4c93-b948-2d981e811b9c","owner":[],"postedDate":"July 13th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-02T18:38:17+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-13 02:32:36","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4577712","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4577712","identity":"rs-4577712","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}