CON: Factor Concentrates Should Not Have an Expanded Role in the Routine Management of the Bleeding Cardiac Surgical Patient

Journal of Cardiothoracic and Vascular Anesthesia

Volumn 32, Issue 1, 2018, Pages 565-569

  Patel, Prakash A ^a   Fabbro, Michael ^b  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

blood loss; factor concentrates; factor VIIa; fibrinogen; hemorrhage; prothrombin complex concentrates (PCC); transfusion therapy

Indexed keywords

FIBRINOGEN CONCENTRATE; PROTHROMBIN COMPLEX; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

BLOOD CLOTTING DISORDER; BLOOD TRANSFUSION; HEART SURGERY; HUMAN; NOTE; OPERATIVE BLOOD LOSS; POSTOPERATIVE HEMORRHAGE; PRIORITY JOURNAL; SURGICAL PATIENT;

EID: 85029413013     PISSN: 10530770     EISSN: 15328422     Source Type: Journal    
DOI: 10.1053/j.jvca.2017.04.021     Document Type: Note

References (42)

1. Ferraris, V.A., Brown, J.R., Despotis, G.J., et al. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg 91 (2011), 944–982.
2. Practice guidelines for perioperative blood management: An updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management. Anesthesiology 122 (2015), 241–275.
3. Novoseven [package insert]. 2006, Novo Nordisk, Inc, Princeton, NJ.
4. Logan, A.C., Yank, V., Stafford, R.S., Off-label use of recombinant factor VIIa in U.S. hospitals: Analysis of hospital records. Ann Intern Med 154 (2011), 516–522.
5. Gill, R., Herbertson, M., Vuylsteke, A., et al. Safety and efficacy of recombinant activated factor VII: A randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation 120 (2009), 21–27.
6. Lin, Y., Moltzan, C., Anderson, D., The evidence for the use of recombinant factor VIIa in massive bleeding: Revision of the transfusion policy framework. Transfus Med 22 (2012), 383–394.
7. Alfirevic, A., Duncan, A., You, J., et al. Recombinant factor VII is associated with worse survival in complex cardiac surgical patients. Ann Thorac Surg 98 (2014), 618–624.
8. Hollis, A.L., Lowery, A.V., Pajoumand, M., et al. Impact on postoperative bleeding and cost of recombinant activated factor VII in patients undergoing heart transplantation. Ann Card Anaesth 19 (2016), 418–424.
9. Simpson, E., Lin, Y., Stanworth, S., et al. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev, 3, 2012 CD005011.
10. Levi, M., Levy, J.H., Andersen, H.F., et al. Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med 363 (2010), 1791–1800.
11. Ghadimi, K., Levy, J.H., Welsby, I.J., Prothrombin complex concentrates for bleeding in the perioperative setting. Anesth Analg 122 (2016), 1287–1300.
12. Franchini, M., Lippi, G., Fibrinogen replacement therapy: A critical review of the literature. Blood Transfus 10 (2012), 23–27.
13. Kozek-Langenecker, S.A., Afshari, A., Albaladejo, P., et al. Management of severe perioperative bleeding: Guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol 30 (2013), 270–382.
14. Levy, J.H., Welsby, I., Goodnough, L.T., Fibrinogen as a therapeutic target for bleeding: A review of critical levels and replacement therapy. Transfusion 54 (2014), 1389–1405.
15. Levy, J.H., Goodnough, L.T., How I use fibrinogen replacement therapy in acquired bleeding. Blood 125 (2015), 1387–1393.
16. Rahe-Meyer, N., Solomon, C., Hanke, A., et al. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: A randomized, placebo-controlled trial. Anesthesiology 118 (2013), 40–50.
17. Bilecen, S., de Groot, J.A., Kalkman, C.J., et al. Effect of fibrinogen concentrate on intraoperative blood loss among patients with intraoperative bleeding during high-risk cardiac surgery: A randomized clinical trial. JAMA 317 (2017), 738–747.
18. Rahe-Meyer, N., Levy, J.H., Mazer, C.D., et al. Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): A double-blind phase III study of haemostatic therapy. Br J Anaesth 117 (2016), 41–51.
19. Waldén, K., Jeppsson, A., Nasic, S., et al. Low preoperative fibrinogen plasma concentration is associated with excessive bleeding after cardiac operations. Ann Thorac Surg 97 (2014), 1199–1206.
20. Jeppsson, A., Waldén, K., Roman-Emanuel, C., et al. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: A randomized controlled study. Br J Anaesth 116 (2016), 208–214.
21. Ozier, Y., Hunt, B.J., Against: Fibrinogen concentrate for management of bleeding: Against indiscriminate use. J Thromb Haemost 9 (2011), 6–8.
22. Tanaka, K.A., Szlam, F., Treatment of massive bleeding with prothrombin complex concentrate: Argument for. J Thromb Haemost 8 (2010), 2589–2591.
23. Profilnine [package insert]. 2014, Grifols Biologicals, Inc., Los Angeles, CA.
24. KCentra [package insert]. 2017, CSL Behring LLC, Kankakee, IL.
25. Glynn, J.C., Plaat, F., Prothrombin complex for massive obstetric haemorrhage. Anaesthesia 62 (2007), 202–203.
26. Schöchl, H., Nienaber, U., Maegele, M., et al. Transfusion in trauma: Thromboelastometry-guided coagulation factor concentrate-based therapy versus standard fresh frozen plasma-based therapy. Crit Care, 15, 2011, R83.
27. Arnékian, V., Camous, J., Fattal, S., et al. Use of prothrombin complex concentrate for excessive bleeding after cardiac surgery. Interact Cardiovasc Thorac Surg 15 (2012), 382–389.
28. Tanaka, K.A., Mazzeffi, M.A., Grube, M., et al. Three-factor prothrombin complex concentrate and hemostasis after high-risk cardiovascular surgery. Transfusion 53 (2013), 920–921.
29. Cappabianca, G., Mariscalco, G., Biancari, F., et al. Safety and efficacy of prothrombin complex concentrate as first-line treatment in bleeding after cardiac surgery. Crit Care, 20, 2016, 5.
30. Sin, J.H., Berger, K., Lesch, C.A., Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation. J Crit Care 36 (2016), 166–172.
31. Goldhammer, J.E., Bakowitz, M.J., Milas, B.L., et al. Intracardiac thrombosis after emergent prothrombin complex concentrate administration for warfarin reversal. Anesthesiology, 123, 2015, 458.
32. Warren, O., Simon, B., Massive, fatal, intracardiac thrombosis associated with prothrombin complex concentrate. Ann Emerg Med 53 (2009), 758–761.
33. Zemrak, W.R., Kelley, E., Kovacic, N.L., et al. Thrombotic complications following the administration of high-dose prothrombin complex concentrate for acute warfarin reversal. Am J Emerg Med, 34, 2016, 1736 e1731–3.
34. Bui, J.D., Despotis, G.D., Trulock, E.P., et al. Fatal thrombosis after administration of activated prothrombin complex concentrates in a patient supported by extracorporeal membrane oxygenation who had received activated recombinant factor VII. J Thorac Cardiovasc Surg 124 (2002), 852–854.
35. Karlsson, O., Jeppsson, A., Hellgren, M., Major obstetric haemorrhage: monitoring with thromboelastography, laboratory analyses or both?. Int J Obstet Anesth 23 (2014), 10–17.
36. Franchini, M., Lippi, G., Manzato, F., Recent acquisitions in the pathophysiology, diagnosis and treatment of disseminated intravascular coagulation. Thromb J, 4, 2006, 4.
37. Sørensen, B., Spahn, D.R., Innerhofer, P., et al. Clinical review: Prothrombin complex concentrates–Evaluation of safety and thrombogenicity. Crit Care, 15, 2011, 201.
38. Grottke, O., Levy, J.H., Prothrombin complex concentrates in trauma and perioperative bleeding. Anesthesiology 122 (2015), 923–931.
39. Bolliger, D., Seeberger, M.D., Tanaka, K.A., Principles and practice of thromboelastography in clinical coagulation management and transfusion practice. Transfus Med Rev 26 (2012), 1–13.
40. Tanaka, K.A., Mazzeffi, M., Durila, M., Role of prothrombin complex concentrate in perioperative coagulation therapy. J Intensive Care, 2, 2014, 60.
41. Godier, A., Susen, S., Samama, C.M., Treatment of massive bleeding with prothrombin complex concentrate: Argument against. J Thromb Haemost 8 (2010), 2592–2595.
42. Goodnough, L.T., Levy, J.H., Off-label use of recombinant human factor VIIa. Ann Thorac Surg 98 (2014), 393–395.