Activated Factor 7 Versus 4-Factor Prothrombin Complex Concentrate for Critical Bleeding Post-Cardiac Surgery. J Am Heart Assoc. Wolters Kluwer Health 26. 0000002434 00000 n Recommendations are to administer 50 units/kg, with an additional 25 units/kg if the patientmeets all the following criteria: It is also recommended to administer vitamin K along with PCC when used for reversal of VKA anticoagulation; thisresults from the long half-life of warfarin requiring sustained reversal that only vitamin K can provide. 61. 2017; 91:3947. Conflicts of Interest: N. B. Hensley has served on the scientific advisory board for Octapharma USA (Paramus, NJ) and received royalties from Wolters Kluwer for uptodate.com contributions. Dose of fibrinogen concentrate (mg) = Target plasma concentration (mg/dL) Measured plasma concentration (mg/dL)/1.7 body weight (kg). In patients weighing greater than 100 kg, the recommendation is to exceed the maximum dose. Contribution: This author helped conceive and design the pro/con manuscript, analyze and interpret the data, and write the manuscript. <> endobj Transfusion. There are at least 4 randomized controlled studies of fibrinogen concentrate in the cardiac surgical patients who did not show benefits in terms of reduced RBC transfusion, reduced platelet transfusion, or reoperations for bleeding.38,4042 Three of these studies utilized fibrinogen concentrate after CPB, and 1 utilized fibrinogen concentrate before CPB. FOIA Acquired von Willebrand syndrome and impaired platelet function during venovenous extracorporeal membrane oxygenation: rapid onset and fast recovery. PCC is leukocyte-free and less likely to cause infusion reactions. Hensley, Nadia B. MD*; Mazzeffi, Michael A. MD, MPH, MSc, FASA, From the *Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland. When 5 single donor units are pooled together, this can be extrapolated to a minimum of 400 IU of factor VIII. Prothrombin complex concentrate offers several advantages over FFP, most importantly, the small volume needed to reverse anticoagulation. When confronted with such complex coagulopathic patients, we have administered the combination of prothrombin complex concentrates (PCCs) with cryoprecipitate as a lower-volume alternative to plasma transfusion. Activated factorV and activated factor X produce thrombin. Name: Michael A. Mazzeffi, MD, MPH, MSc, FASA. Low levels of factor XIII are associated with increased postoperative bleeding and reoperation for bleeding in the cardiac surgery.55 Factor XIII administration was previously found to reduce blood loss in the CABG patients, when given at a dose of 1250 or 2500 IU.56 Unfortunately, these results were not replicated in a larger study of cardiac surgical patients, where 17.5 and 35 IU/kg doses were administered, and there was no reduction in allogeneic transfusion or reoperation.57 Nevertheless, in patients with excessive hemodilution or in those with major blood loss, the additional factor XIII activity that is present in the cryoprecipitate may be beneficial in achieving hemostasis. endobj World J Pediatr Congenit Heart Surg. 0000006800 00000 n Pharmacotherapy. Sniecinski RM, Chandler WL. Factor XIII activity in patients requiring surgical re-exploration for bleeding after elective cardiac surgerya prospective case control study. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: the FIBRES randomized clinical trial. There were no differences observed in the number of packed red blood cells (4-factor PCC: 2 units vs. rFVIIa: 2 units), fresh frozen plasma (0 units vs. 1 unit) or platelet (2 units vs. 2 units) transfusions following the administration of 4-factor PCC or rFVIIa. [1] [3] It may also be used for reversal of warfarin therapy. 22. A Comparison of Prothrombin Complex Concentrate and - PubMed American Red Cross, Accessed November 27, 2020. Prothrombin complex concentrate doses received before CPB end, such as for warfarin reversal, were not included in the analysis (n = 25). Cryoprecipitate is derived from fresh frozen plasma (FFP), which is frozen within 8 hours of collection. [11], Higher doses of PCC can increase the risk of thromboembolism. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? 0000049748 00000 n 0000011914 00000 n 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. Administration of Prothrombin Complex Concentrate vs. Standard Harper PC, Smith MM, Brinkman NJ, Passe MA, Schroeder DR, Said SM, Nuttall GA, Oliver WC, Barbara DW. Life-threatening Major Bleed With a Non-Warfarin Anticoagulant. Bilecen et al42 randomized patients (n = 120) having complex cardiac surgery (CABG + valve, multivalve, aortic root, ascending aorta, or arch repair) to receive fibrinogen concentrate or placebo if there was post-CPB bleeding >60 mL after attempts at surgical hemostasis. FFP requires procurement from the blood bank and thawing before administration, factors that lead to delays in administration and anticoagulation reversal. Blood products - Transfusion Guidelines 2018 Feb;32(1):151-157. doi: 10.1053/j.jvca.2017.07.011. endobj The treatment with fibrinogen concentrate will not replace VWF multimers, and poor platelet adhesion may persist despite normalization of fibrinogen. Mazzeffi M, Hasan S, Abuelkasem E, et al. 2020. 10>a Solomon et als43 pharmacovigilance evaluation of fibrinogen concentrate over a 27-year period specifically analyzed the risk of thromboembolism. Rahe-Meyer N, Pichlmaier M, Haverich A, et al. sharing sensitive information, make sure youre on a federal Accessed November 27, 2020. Cryoprecipitate - (See "Clinical use of Cryoprecipitate" .) Prothrombin complex concentrate (PCC) comes from the process of ion-exchange chromatography from the cryoprecipitate supernatant of large plasma pools and after removal of antithrombin and factor XI. <> 21. Individualized dosing is based on the severity of the disorder, extent and location of bleeding, and clinical status of the patient. endobj 2009; 108:751758. Cappy P, Candotti D, Sauvage V, et al. endobj [1] Some versions also contain factor VII. PCC are . 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. 20. Furthermore, when the surgical setting is cardiothoracic, volume overload may promote catastrophic wound or graft dehiscence. Fibronectin promotes platelet adhesion, increases the diameter of fibrin fibers, and strengthens thrombi.58,59 Alternatively, fibronectin inhibits thrombus formation in the absence of fibrin, helping to maintain normal vascular integrity.60 Fibronectin may be particularly important in patients with hypofibrinogenemia because it helps to solidify and strengthen fibrin mesh.58,60. Karkouti K, von Heymann C, Jespersen CM, et al. JAMA Intern Med. The .gov means its official. 2018 Nov 17 [PubMed PMID: 30458156], Sellers W,Bendas C,Toy F,Klock B,Kerestes J,Young A,Badger C,Jensen J,Becker N, Utility of 4-Factor Prothrombin Complex Concentrate in Trauma and Acute-Care Surgical Patients. <> Fabes J, Brunskill SJ, Curry N, Doree C, Stanworth SJ. 2019; 59:15601567. The influence of perioperative coagulation status on postoperative blood loss in complex cardiac surgery: a prospective observational study. Postmarketing surveillance reports angioedema, bronchospasm, and other severe thromboembolic complications (e.g., myocardial infarction, transient ischemic attack, and arterial thrombosis). 12. A recent meta-analysis of randomized controlled trials of fibrinogen concentrate in the cardiac surgical patients suggested that the fibrinogen concentrate decreases RBC transfusion (relative risk [RR] = 0.64; 95% CI, 0.49-0.83), but there was no reduction in other transfusions (eg, platelets and plasma), and there was no reduction in the reoperations for bleeding.49 Taken together, the current evidence supporting the routine use of fibrinogen concentrate in the cardiac surgical patients is not particularly strong, even when the treatment is based on the whole blood viscoelastic coagulation testing. Address correspondence to Nadia B. Hensley, MD, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 1800 Orleans Ave, Zayed Tower 6212, Baltimore, MD 21287. Witmer CM, Huang YS, Lynch K, Raffini LJ, Shah SS. 52. <> Efficacy of fibrinogen concentrate in major abdominal surgerya prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei. Their main authorized indication is reversal of the effects of oral anticoagulants (vitamin K antagonists, VKAs). Epub 2018 Jan 13. One vial of PCC also contains factors II, VII, IX, X, Proteins C and S, Antithrombin III and a small amount of heparin. 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. 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 . 37 0 obj 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. National Library of Medicine 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). <> PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding <> 19. Fibrinogen concentrate was given based on the rotational thromboelastometry (ROTEM; TEM International, Munich, Germany) parameters.39 Fifteen minutes after fibrinogen concentrate was given, patients could receive prothrombin complex concentrate if ROTEM parameters remained abnormal. 50. 36. HHS Vulnerability Disclosure, Help 45 0 obj 2005; 19:459467. Package insert. 2006; 54:2633. Prothrombin complex concentrate vs. fresh frozen plasma in adult We compared the standard dosage of FFP and PCC in terms of efficacy and safety for patients with mechanical heart valves undergoing interventional procedures while receiving Warfarin.
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cryoprecipitate vs prothrombin complex concentrate