Journal of Cardiothoracic and Vascular Anesthesia
Volume 23, Issue 1 , Pages 28-33 , February 2009

Recombinant Factor VIIa Treatment of Severe Bleeding in Cardiac Surgery Patients: A Retrospective Analysis of Dosing, Efficacy, and Safety Outcomes

  • Faisal Masud, MD, FCCP

      Affiliations

    • Methodist Hospital, Houston, TX
    • Corresponding Author InformationAddress reprint requests to Faisal Masud, MD, FCCP, Department of Anesthesiology, Methodist Hospital, 6565 Fannin Street, B452, Houston, TX 77030
    • ,
  • Fariedeh Bostan, PharmD

      Affiliations

    • Methodist Hospital, Houston, TX
    • ,
  • Elisa Chi, PharmD

      Affiliations

    • Methodist Hospital, Houston, TX
    • ,
  • Steven E. Pass, PharmD, FCCM

      Affiliations

    • University of Houston College of Pharmacy, Houston, TX
    • ,
  • Hany Samir, MD

      Affiliations

    • Methodist Hospital, Houston, TX
    • ,
  • Karla Stuebing, PhD

      Affiliations

    • University of Houston TIMES, Houston, TX
    • ,
  • Michael G. Liebl, PharmD

      Affiliations

    • Methodist Hospital, Houston, TX

References 

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  2. Karthik S, Grayson AD, McCarron EE, et al. Reexploration for bleeding after coronary artery bypass surgery: Risk factors, outcomes, and the effect of time delay. Ann Thorac Surg. 2004;78:527–534
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  5. NovoSeven prescribing information. Princeton, NJ: NovoNordisk Inc; October 2006;http://www.novoseven-us.com/Version 10
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  9. Shao YF, Yang JM, Chau GY, et al. Safety and hemostatic effects of recombinant activated factor VII in cirrotic patients undergoing partial hepatectomy: A multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg. 2006;191:245–249
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  11. Friederich PW, Henny CP, Messelink EJ, et al. Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: A double-blind placebo-controlled randomised trial. Lancet. 2003;361:201–205
  12. Diprose P, Herbertson MJ, O'Shaughnessy D, et al. Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex noncoronary cardiac surgery: Randomized double-blind placebo-controlled pilot study. Br J Anaesth. 2005;95:596–602
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  16. Hyllner M, Houltz E, Jeppsson A. Recombinant activated factor VII in the management of life-threatening bleeding in cardiac surgery. Eur J Cardiothorac Surg. 2005;28:254–258
  17. Aggarwal A, Malkovska V, Catlett JP, et al. Recombinant activated factor VII (rFVIIa) as salvage treatment for intractable hemorrhage. Thromb J. 2004;2:9
  18. Hendriks HG, van der Maaten J, de Wolf J, et al. An effective treatment of severe intractable bleeding after valve repair by one single dose of activated recombinant factor VII. Anesth Analg. 2001;93:297-289
  19. McCall P, Story D, Karapillai D. Audit of factor VIIa for bleeding resistant to conventional therapy following complex cardiac surgery. Can J Anesth. 2006;53:926–933
  20. Heymann C, Redlich U, Gain U, et al. Recombinant activated factor VII for refractory bleeding after cardiac surgery—A retrospective analysis of safety and efficacy. Crit Care Med. 2005;33:2241–2246
  21. Dunkley S, Phillips L, McCall P, et al. Recombinant activated factor VII in cardiac surgery: Experience from the Australian and New Zealand Haemostatis Registry. Ann Thorac Surg. 2008;85:836–844
  22. Levi M, Peters M, Buller HR. Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: A systematic review. Crit Care Med. 2005;33:883–889
  23. Dietrich W, Spannagl M. Caveat against the use of activated recombinant factor VII for intractable bleeding in cardiac surgery. Anesth Analg. 2002;94:1369–1370
  24. Warren O, Mandal K, Hadjianastassiou V, et al. Recombinant activated factor VII in cardiac surgery: A systematic review. Ann Thorac Surg. 2007;83:707–714
  25. The Society of Thoracic Surgeons Adult Cardiac Surgery Database Data Specifications. Version 2.52.1. Ann Thorac Surg. April 9, 2004;83:117–130http://www.sts.org/sections/stsnationaldatabase/datamanagers/adultcardiacdb/datacollection/index.html
  26. Rady MY, Ryan T, Starr NJ. Perioperative determinants of morbidity and mortality in elderly patients undergoing cardiac surgery. Crit Care Med. 1998;26:225–235
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  30. Clark AD, Gordon WC, Tait RC. “Last ditch” use of recombinant factor VIIa in patients with massive haemorrage is ineffective. Vox Sang. 2004;86:120–124
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  37. Flynn JD, Pajoumand M, Camp PC, et al. Recombinant factor VIIa for refractory bleeding following orthotopic heart transplantation. Ann Pharmacother. 2004;38:1639–1642
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  39. Mangano DT, Tudor I, Dietzl C. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006;354:353–365
  40. Karkouti K, Beattie WS. Pro: The role of recombinant factor VIIa in cardiac surgery. J Cardiothorac Vasc Anesth. 2008;22:779–782

 F.M. received a research grant from NovoNordisk, manufacturers of recombinant factor VIIa, in the amount of $5,000.00.

PII: S1053-0770(08)00235-8

doi: 10.1053/j.jvca.2008.08.003

Journal of Cardiothoracic and Vascular Anesthesia
Volume 23, Issue 1 , Pages 28-33 , February 2009

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