Anesthesia & Analgesia133(1):19-28, July 2021. Cushing MM, Haas T. Fibrinogen concentrate for perioperative bleeding: what can we learn from the clinical trials? Jeppsson A, Waldn K, Roman-Emanuel C, Thimour-Bergstrm L, Karlsson M. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: a randomized controlled study. endobj PCC contains significantly higher amounts of the clotting factors compared to FFP; one dose of PCC equals 8 to 16 units of FFP. In patients where bleeding is related to coagulation factor deficiency, prothrombin complex concentrates (PCC), or fresh frozen plasma (FFP) administration should be considered to reduce bleeding and transfusions (Boer et al. Asian J Transfus Sci. 51. Prothrombin Complex Concentrate Four factor PCC (Kcentra) is dosed on the amount of factor IX. 1979; 241:16901691. The total median dose requirement for 4-factor PCC was 1000 units (15 units/kg) and 2 mg (20 mcg/kg) for rFVIIa. Anesth Analg. endobj Cappy et al30 reported that between January 20 and May 29 of 2020, 311 blood donations to the French National Blood Service were investigated including 268 postdonation infections (PDIs) and 43 trace-back donations (patients who reported COVID-19 symptoms within 14 days of donation). 58. PCC products have a lower risk of viral transmission since they undergo viral inactivation. endobj In all the indications listed above, 4-factor PCC is the preferredchoice. Furthermore, evidence supporting the routine or prophylactic use of fibrinogen concentrate in the cardiac surgical patients is not robust, and larger studies are needed to confirm its value compared to cryoprecipitate, which has been the gold standard for treating acquired hypofibrinogenemia for almost 50 years. Acquired von Willebrand syndrome associated with left ventricular assist device. Am J Hematol. The indications are listed below. Rahe-Meyer et al36 conducted another small randomized trial in patients undergoing elective aortic valve and ascending aortic replacement surgery. Factor XIII, also known as fibrin stabilization factor, is contained in cryoprecipitate and its presence may add to cryoprecipitates superiority over fibrinogen concentrate in patients having complex cardiac surgery. 0000005449 00000 n Cryoprecipitate as a reliable source of fibrinogen replacement. Tanaka KA, Egan K, Szlam F, et al. Fibrinogen concentrate can be stored at room temperature and is easily reconstituted in sterile water within 510 minutes. J Pediatr. The FIBRES study reported a 2.6% higher thromboembolism rate in patients who received cryoprecipitate at 9.6% compared to 7.0% in patients who received fibrinogen concentrate (Table 1); however, this difference was not statistically different.24, Another randomized controlled trial, which included patients with pseudomyxoma peritonei and cytoreductive surgery, found a higher incidence of thromboembolic events in the cryoprecipitate group at 30.4% (7 of 23) compared to 0% (0 of 22) in the fibrinogen concentrate group.44 In a recent systematic review of randomized controlled trials examining fibrinogen concentrate, the authors concluded that the overall risk of thromboembolism is probably extremely low, and no studies reported a significantly increased risk of thromboembolism in patients receiving fibrinogen concentrate.20, Despite the findings of the FIBRES study, cryoprecipitate may be superior in some cardiac surgical patients.24 In the FIBRES study, the median CPB duration was 130140 minutes, but the CPB duration is often longer in complex aortic surgery with deep hypothermic circulatory arrest or in the other combined cardiac surgery procedures. Explain the importance of improving care coordination among the interprofessional team to enhance care delivery for patients who can benefit from therapy with prothrombin complex concentrate. <> 37 0 obj 2020. Before This agent's initial development was for hemophilia; however, with the availability of recombinant replacement factors, it no longer has a use in this setting. The patients in the rFVIIa group, required more cryoprecipitate than those in the 4-factor PCC group (4-factor PCC: 2 units (range 0-6) vs. rFVIIa: 2 units (range 0-8), p = 0.03). 32. Bachowski GBD, Brunker PAR, Eder A, et al. However, the small difference in a chest tube output observed in this study may not be clinically significant.42 The limitations of this small, single-center trial were that 6 patients (10%) in the control group were given fibrinogen concentrate postoperatively, confounding the studys results, and the chest tube output is well known to have limitations as a surrogate for bleeding. 1, 2021, p. 34-39. [3] 46 0 obj Callum J, Farkouh ME, Scales DC, et al. Disclaimer. You may be trying to access this site from a secured browser on the server. Bilecen S, de Groot JA, Kalkman CJ, et al. PCC is leukocyte-free and less likely to cause infusion reactions. CSL Behring; Accessed November 27, 2020. Experts have stated that in cases where 4-factor PCC is unavailable, 3 factor PCC with recombinant factor VII is an acceptable alternative. US Food and Drug Administration. J Heart Lung Transplant. Research output: Contribution to journal Article peer . Prothrombin complex concentrates (PCCs) are a source of the vitamin K-dependent coagulation factors, including factors II, VII, IX and X and proteins C and S. They are isolated from the cryoprecipitate supernatant of large plasma pools after removal of antithrombin and factor XI. Another advantage of fibrinogen concentrate is that it can be rapidly reconstituted and administered to patients. Although this may seem trivial, off-label drug use is associated with a 1.5-fold higher incidence of serious adverse drug events.46 Furthermore, a significant amount of pharmacovigilance time may be needed to identify a pattern of increased thromboembolic risk. 15. Please enable scripts and reload this page. HHS Vulnerability Disclosure, Help Franchini M, Lippi G. Fibrinogen replacement therapy: a critical review of the literature. 40. J Thromb Haemost. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. 16. This extrapolates to ~1 thromboembolic event per 23,300 doses of 4 g of fibrinogen concentrate or an absolute risk of 0.004%. 2011; 25:267292. 0000014998 00000 n Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding. Adult cardiac surgery, Fresh Frozen Plasma (FFP), Cryoprecipitate, Prothrombin Complex Concentrate (PCCs) The . Prothrombin complex concentrates (PCCs) are a source of the vitamin K-dependent coagulation factors, including factors II, VII, IX and X and proteins C and S. They are isolated from the cryoprecipitate supernatant of large plasma pools after removal of antithrombin and factor XI. Eguale T, Buckeridge DL, Verma A, et al. 2012; 10:2327. RiaSTAP Fibrinogen Concentrate (Human). The shelf life is also much longer for fibrinogen concentrate (3 years) compared to cryoprecipitate (1 year), which may be important in smaller, rural hospitals that have a less frequent need for fibrinogen therapy.61 There is also a longer shelf life after reconstitution because fibrinogen concentrate is able to be used for 24 hours after reconstitution versus 6 hours after cryoprecipitate thaws. European journal of anaesthesiology. Epub 2017 Jul 12. 36. In conclusion, current evidence suggests that the risk of transmission of SARS-CoV-2 through the blood supply is exceedingly low. Best Pract Res Clin Anaesthesiol. Prothrombin complex concentrate offers several advantages over FFP, most importantly, the small volume needed to reverse anticoagulation. Cryoprecipitate is derived from fresh frozen plasma (FFP), which is frozen within 8 hours of collection. The trial was stopped prematurely due to noninferiority being satisfied.24, Because cryoprecipitate is not a purified product and contains platelet microparticles, fibronectin, Factor VIII, and VWF, there may be an increased thromboembolic risk. Patients were included if they were at least 18 years of age and had undergone cardiac surgery with bleeding requiring intervention with 4-factor PCC or rFVIIa. Ranucci et al39 enrolled 116 cardiac surgical patients and randomized them to receive either fibrinogen concentrate or placebo after protamine was given. No evidence of SARS-CoV-2 transfusion transmission despite RNA detection in blood donors showing symptoms after donation. Haemophilia. Efficacy of fibrinogen concentrate in major abdominal surgerya prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei. 47. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: the FIBRES randomized clinical trial. Package insert. The initial development of this agent was for hemophilia; however, with the availability of recombinant replacement factors, it no longer has a use in this setting. Anesthesia & Analgesia. . 55. Crit Care. N Engl J Med. 2006; 4:14611469. 2008 Nov [PubMed PMID: 18946305], Josef AP,Garcia NM, Systemic Anticoagulation and Reversal. endobj Fibrinogen or cryoprecipitate - Targeting a slightly higher level than usual might be helpful, but evidence on this is scant. Mehringer SL, Klick Z, Bain J, McNeely EB, Subramanian S, Pass LJ, Drinkwater D, Reddy VS. Ann Pharmacother. JAMA Intern Med. ; Society of Thoracic Surgeons Blood Conservation Guideline Task F. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. In December 2019, a novel human coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in China, where the first case of coronavirus disease 2019 (COVID-19) was described.28 AABB, formerly known as the American Association of Blood Banking, and the US FDA have stated that there are no reported cases of SARS-CoV-2 infection related to blood transfusion.29 Careful screening of blood donors through questionnaires and routine temperature checks, as well as volunteer reporting of COVID-19 symptoms within 48 hours of blood donation, have apparently kept the blood supply safe. Cryoprecipitate therapy. 2013; 117:1422. 2023 May;14(3):282-288. doi: 10.1177/21501351231162911. endobj <> 2017. Cryoprecipitate has been the gold standard for treating acquired hypofibrinogenemia in cardiac surgery for nearly 50 years. Review both the approved and off-label indications for using prothrombin complex concentrate. Mol Pharmacol. Four immunocompromised recipients (aged 567 years) were involved in trace-back donations and received 225 blood products including 18 RBCs and 23 pathogen-reduced platelets. Anesth Analg. N Engl J Med. to maintaining your privacy and will not share your personal information without Even though allogeneic blood products have been screened since 1985 with nucleic acid testing for viruses such as hepatitis C and human immunodeficiency virus (HIV), it is impractical to screen for all viruses or emerging infectious diseases. 54. Patients with aortic stenosis have loss of large VWF multimers due to high shear stress, which is referred to as Heyde syndrome.50 The Heyde syndrome is similar to type 2a VWD, where there is a loss of VWF function and poor platelet adhesion to collagen. 2019; 59:32953297. J Crit Care. 38. 2020; 136:18881891. A total of 13 patients (18%) in the PCC group . PU/dR,*qM*biemG 49 0 obj Cochrane Database Syst Rev. Cryoprecipitate has been available for transfusion since 1964; initially as therapy for haemophilia A, then rapidly becoming first line treatment for von Willebrand's disease and heritable deficiencies of fibrinogen and FXIII 1.With the advent of single-factor concentrate therapy the number of clinical indications for cryoprecipitate has reduced. 35 0 obj For more information, please refer to our Privacy Policy. Get new journal Tables of Contents sent right to your email inbox, http://journals.lww.com/anesthesia-analgesia/pages/default.aspx, http://success.redcross.org/success/file.php/1/TransfusionPractices-Compendium_3rdEdition.pdf, https://www.fda.gov/media/105864/download, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=606.122, https://onlinelibrary.wiley.com/doi/10.1111/hae.14046, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-blood-establishments-regarding-covid-19-pandemic-and-blood-donation, Pro-Con Debate: Fibrinogen Concentrate or Cryoprecipitate for Treatment of Acquired Hypofibrinogenemia in Cardiac Surgical Patients, Articles in PubMed by Nadia B. Hensley, MD, Articles in Google Scholar by Nadia B. Hensley, MD, Other articles in this journal by Nadia B. Hensley, MD, Update on Applications and Limitations of Perioperative Tranexamic Acid, Society of Cardiovascular Anesthesiologists Clinical Practice Improvement Advisory for Management of Perioperative Bleeding and Hemostasis in Cardiac Surgery Patients, Blood Conservation and Hemostasis in Cardiac Surgery: A Survey of Practice Variation and Adoption of Evidence-Based Guidelines, Intraoperative Management of Adult Patients on Extracorporeal Membrane Oxygenation: An Expert Consensus Statement From the Society of Cardiovascular AnesthesiologistsPart II, Intraoperative Management and Troubleshooting, Red Blood Cell Transfusion and Postoperative Infection in Patients Having Coronary Artery Bypass Grafting Surgery: An Analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database, Privacy Policy (Updated December 15, 2022), International Anesthesia Research Society, Standard concentration of ~1 g per vial, after reconstitution becomes 1 g per 50 mL, Variable concentration of ~120796 mg per 15 mL in each individual single donor unit, Nucleic acid testing for HIV, hepatitis A, B, and C, and human parvovirus in donor plasma units, Nucleic acid testing for HIV, hepatitis B and C, and other viruses, Additional viral inactivation through precipitation/adsorption/pasteurization processes, Fibrinogen and other coagulation factors including VWF, FVIII, FXIII, fibronectin, and platelet microparticles, Secondary hemostasis by increasing substrate for thrombin, Primary hemostasis by increasing VWF and platelet microparticles, Secondary hemostasis by increasing substrate for thrombin and FVIII activity (intrinsic tenase activity), Rapid reconstitution in minutes can be rapidly administered to the patient after reconstitution, Kept frozen at 20 C and requires 3045 min to thaw, once available can be rapidly administered to the patient, Shelf life after reconstitution or thawing, Shelf life is up to 24 h after reconstitution, Limited shelf life after thawing of 46 h; FVIII activity degrades relatively quickly, fibrinogen is more stable, Negligible risk of alloimmunization, TACO, TRALI, Low, but present risk of allergic transfusion reactions, alloimmunization, and other transfusion adverse events (TACO or TRALI), Acquisition cost of ~$1000 per 1 g in the United States, lower acquisition cost in Europe and Canada of ~$400$500 per 1 g, Acquisition cost of ~$300$400 per 56 unit pool in the United States, Additional hidden costs include blood bank processing (~45 min to 1 h) and wastage, which increase the total cost, No detectable adverse events; 1 vein graft occlusion in the FC group; LIMA grafts patient in both groups, Elective AVR and ascending aorta replacement, Postbypass with signs of clinical bleeding, Dose based on the MCF on FIBTEM; mean, 5.7 0.7 g, Transfusion of allogeneic blood products after CPB in 24 h postop, Significantly fewer RBC, FFP, and platelet transfusions in the FC group, Significantly lower chest tube output in the FC group, Elective valve replacement/repair, double valve, or valve + CABG, Hemostatic scores similar between groups; no differences in RBC, FFP, cryo transfusions between groups; less platelets in the FC group, Elective complex surgery with >90 min CPB and at least 1 risk factor, Dose based on MCF on FIBTEM for target = 22 mm, Avoidance of any allogeneic blood products up to 30 d postop. <> National Library of Medicine Currently, cryoprecipitate is rarely used to treat hemophilia A and VWD because concentrated, lyophilized, plasma-derived, and recombinant products are available for both diseases. Transfusion. Subramaniyan R, Marwaha N, Jain A, Ahluwalia J. WFH Guidelines for the Management of Hemophilia. Dose of fibrinogen concentrate (mg) = Target plasma concentration (mg/dL) Measured plasma concentration (mg/dL)/1.7 body weight (kg). Karkouti K, McCluskey SA, Syed S, Pazaratz C, Poonawala H, Crowther MA. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. JAMA. PCC dosing products are expressed as units of factor IX. 2022 Nov 21;11(11):CD013551. Four-factor prothrombin complex concentrate in adjunct to whole blood in trauma-related hemorrhage : Does whole blood replace the need for factors? It remains unclear whether fibrinogen concentrate will have equal efficacy in these types of cases where CPB duration is 200300 minutes.24, Fibrinogen concentrate is very costly in the United States. Anesth Analg. Describe the mechanism of action of prothrombin complex concentrate. One donor positive platelet unit was pathogen reduced and transfused 3 days after donation to a patient who remained asymptomatic, and a red blood cell (RBC) unit was given to a SARS-CoV-2positive patient. Shander A, Hofmann A, Gombotz H, Theusinger OM, Spahn DR. Estimating the cost of blood: past, present, and future directions. Br J Anaesth. Unable to load your collection due to an error, Unable to load your delegates due to an error. In vitro and observational studies have demonstrated the importance of fibrinogen replacement for adequate hemostasis, yet randomized controlled trials of fibrinogen treatment compared to placebo have not shown a mortality benefit.19 Cushing and Haas20 examined these clinical trials and determined that fibrinogens inconsistent efficacy may be related to design flaws in the trials themselves, including variable definitions for hypofibrinogenemia, inclusion of patients with insignificant bleeding, and off-protocol interventions. Ann Thorac Surg. More recently, fibrinogen concentrate has been used off-label in the United States and is the standard in European countries and Canada to treat the acquired hypofibrinogenemia during cardiac surgery. 3rd ed. 2009; 102:137144. The FDA-approved indication is for urgent reversal of acquired coagulation factor deficiency induced by warfarin-induced anticoagulation in patients presenting with major acute bleeding (intracerebral hemorrhage-ICH) or needing urgent invasive surgery or procedure. Fibrinogen, which is a plasma glycoprotein that is made in the liver (half-life of ~100 hours), is a critical substrate for thrombin. The https:// ensures that you are connecting to the Koch C, Li L, Figueroa P, Mihaljevic T, Svensson L, Blackstone EH. FC group 50 mL (29100) versus placebo 70 mL (33145), Cardiac surgery with CPB and fibrinogen replacement necessary, Postbypass with plasma fibrinogen level <2.0 g/L, Cumulative allogeneic blood product units (RBC, FFP, platelets), Noninferiority criteria met; mean 24 h postbypass cumulative transfusions 16.3 (95% CI, 14.9-17.8) vs 17.0 (95% CI, 15.6-18.6). PCC are . Gdje O, Gallmeier U, Schelian M, Grnewald M, Mair H. Coagulation factor XIII reduces postoperative bleeding after coronary surgery with extracorporeal circulation. Transfusion. 30. 50 0 obj In a review of 14 individual studies of the reversal of warfarin anticoagulation, there were five thrombotic events in 308 patients who received 4-factor prothrombin complex concentrates and two in 161 patients who were given 3-factor prothrombin complex concentrates, although none of the adverse events was deemed clinically significant [11].The risk is therefore low, but it ought to be . History of DIC (disseminated intravascular coagulation), Angina, myocardial infarction, peripheral vascular disease, or stroke in the last three months, Thromboembolic disease event history in the previous three months, Known anaphylactic or severe systemic reactions to prothrombin complex concentrate,albumin hypersensitivity, heparin hypersensitivity, plasma protein hypersensitivity, Labor, obstetric delivery, pregnancy: PCC effect on the fetus is unknown - it is not recommended to use PCC in pregnant patients or during labor unless clearlyindicated and benefits outweigh the risk, Breastfeeding: It is unknown if PCC gets excreted in breast milk - it may be used only if benefits clearlyoutweigh the risks; suspend breastfeeding while receiving PCC, Hepatitis, infection: there is a risk of viral transmission as with all other blood products - although this risk is significantly lower in PCC compared to FFP, Patients with non-survivable acute injuries or illness, Prothrombin time (PT), activated partial thromboplastin time (PTT), fibrinogen, Signs and symptoms of thromboembolism during and after administration of PCC, Feel free to get in touch with us and send a message. 0000016232 00000 n <> When frozen cryoprecipitate is thawed for transfusion, it must be used within 6 hours and cannot be refrozen. Transfusion. 33 0 obj 0000013134 00000 n 2018; 37:985991. 169 0 obj <> endobj Individualized dosing is based on the severity of the disorder, extent and location of bleeding, and clinical status of the patient. 0000005333 00000 n 2018 Dec 13 [PubMed PMID: 30548883], Levy JH,Tanaka KA,Dietrich W, Perioperative hemostatic management of patients treated with vitamin K antagonists. 19. 13. government site. 41 0 obj Hoffman M, Jenner P. Variability in the fibrinogen and von Willebrand factor content of cryoprecipitate. 2018 Dec 1 [PubMed PMID: 30476990], Schulman S,Bijsterveld NR, Anticoagulants and their reversal. World J Pediatr Congenit Heart Surg. More recently, fibrinogen concentrate has been used off-label in the United States and is the standard in European countries and Canada to treat the acquired hypofibrinogenemia during cardiac surgery. Lang T, Johanning K, Metzler H, et al. Transfusion of platelets and/or cryoprecipitate is permitted if abnormal laboratory values are observed during the rewarming phase of CPB; platelet count <100 x 103/l, and fibrinogen <200 mg/dl, respectively. 2015; 113:759771. 1999 Aug 15 [PubMed PMID: 10499903], Tomaselli GF,Mahaffey KW,Cuker A,Dobesh PP,Doherty JU,Eikelboom JW,Florido R,Hucker W,Mehran R,Mess SR,Pollack CV Jr,Rodriguez F,Sarode R,Siegal D,Wiggins BS, 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. Roy A, Stanford S, Nunn S, et al. Cho J, Mosher DF. 2016 Nov [PubMed PMID: 27726162], Kopko PM,Bux J,Toy P, Antibodies associated with TRALI: differences in clinical relevance. Address e-mail to [emailprotected]. Br J Anaesth. 6. Acquisition cost is approximately $1000 per 1 g. In comparison, a pooled cryoprecipitate unit (5 donor pool) costs around $300 to acquire, but there are also processing costs and significant costs related to wastage. 0000009440 00000 n Cryoprecipitate contains factor VIII, von Willebrand factor (VWF), fibrinogen, factor XIII, and fibronectin. 2017. Ten to 15% of the United States blood supply is transfused in cardiac surgical patients.1 Multiple factors including fibrinogen concentration impact bleeding and transfusion risk in cardiac surgical patients.24 About 15 years ago, most European countries removed cryoprecipitate from their markets and began to use fibrinogen concentrate for the treatment of acquired hypofibrinogenemia, mainly because of its superior safety profile. The treatment with fibrinogen concentrate will not replace VWF multimers, and poor platelet adhesion may persist despite normalization of fibrinogen. For the primary outcome of intraoperative bleeding, there was no difference between the fibrinogen concentrate group (median, 50 mL; IQR, 29100 mL) and the control group (median, 70 mL; IQR, 33145 mL; P = .19) with an absolute difference of 20 mL (95% CI, 1335 mL). In this document, the FDA describes the minimum factor VIII activity that is required for a single donor cryoprecipitate unit, which is 80 international units (IUs). There is equipoise regarding the use of prothrombin complex concentrate vs. fresh frozen plasma in bleeding patients undergoing cardiac surgery. Wiley Online Library, Accessed November 25, 2020. Judith Graham Pool and the discovery of cryoprecipitate. Wang Y, Carrim N, Ni H. Fibronectin orchestrates thrombosis and hemostasis. The effects of fibrinogen levels on thromboelastometric variables in the presence of thrombocytopenia. The relationship between fibrinogen levels after cardiopulmonary bypass and large volume red cell transfusion in cardiac surgery: an observational study. The site is secure. <> Similar to other allogeneic blood products, cryoprecipitate undergoes nucleic acid testing for HIV, hepatitis B, and hepatitis C. Yet, it does not undergo viral inactivation, as it occurs with fibrinogen concentrate. 2011; 113:13191333. may email you for journal alerts and information, but is committed 38 0 obj 2010 Jul [PubMed PMID: 20671873], Rowe AS,Mahbubani PS,Bucklin MH,Clark CT,Hamilton LA, Activated Prothrombin Complex Concentrate versus Plasma for Reversal of Warfarin-Associated Hemorrhage. endobj 41. Br J Anaesth. %PDF-1.4 % 1. acquired deficiency of prothrombin complex coagulation factors when rapid correction of the deficiency is required 2. congenital deficiency of any of the vitamin K dependant coagulation factors when purified specific coagulation factors are unavailable Prothromplex T Not licensed for use in UK but may be made available on named patient basis. stream 0000014668 00000 n Sadeghi M, Atefyekta R, Azimaraghi O, et al. Medizinische Klinik, Intensivmedizin und Notfallmedizin. 33. 2018 Sep 24 [PubMed PMID: 30244638], Roman M,Biancari F,Ahmed AB,Agarwal S,Hadjinikolaou L,Al-Sarraf A,Tsang G,Oo AY,Field M,Santini F,Mariscalco G, Prothrombin complex concentrate in cardiac surgery: A systematic review and meta-analysis. This activity outlines the indications, mechanism of action, methods of administration, significant adverse effects, contraindications, monitoring, and toxicity of prothrombin complex concentrate, so providers can direct patient therapy in treating conditions for which it is indicated, as part of the interprofessional team. 1990; 93:694697. The authors found that 67.2% of patients in the treatment arm avoided any allogeneic transfusion (primary outcome) compared to 44.8% in the control group (odds ratio [OR], 0.40; 95% confidence interval [CI], 0.19-0.84). CFR-Code of Federal Regulations Title 21. <> Ranucci M, Baryshnikova E, Crapelli GB, Rahe-Meyer N, Menicanti L, Frigiola A; Surgical Clinical Outcome REsearch (SCORE) Group. We performed a pilot randomised controlled trial to determine the recruitment rate for a large trial, comparing the impact of prothrombin complex concentrate vs. fresh frozen plasma on haemostasis (1 h .
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