Use of recombinant factor VIIa in the perioperative period

M. Levi

doi:10.1055/s-0037-1616943

Hämostaseologie, Table of Contents

Hamostaseologie 2009; 29(01): 68-70
DOI: 10.1055/s-0037-1616943

Original article

Schattauer GmbH

Use of recombinant factor VIIa in the perioperative period

M. Levi

¹Department of Medicine and Vascular Medicine, Academic Medical Center, University of Amsterdam

› Author Affiliations

Abstract

Summary

Recombinant activated factor VII (rFVIIa) is a pro-haemo -static agent that can be used for patients with haemophilia and inhibiting antibodies towards a coagulation factor. Recombinant factor VIIa is, however, increasingly used for several other indications, including patients who experience serious and life-threatening bleeding. In addition, rFVIIa has been evaluated for the prevention of major blood loss in patients undergoing surgical procedures that are known to be associated with major blood loss. In this manuscript we review the data on efficacy and safety of rFVIIa in the prevention of excessive blood loss and trans-fusion requirements in the perioperative period.

We conclude that recombinant factor VIIa is a promising agent for perioperative prevention of major blood loss but that its efficacy will probably vary between specific clinical settings. Its exact place in surgery warrants further clinical trials in various situations that will also more precisely determine the safety of this intervention.

Keywords

Factor VIIa

Full Text

References

References
1 Hedner U, Kisiel W. Use of human factor VIIa in the treatment of two hemophilia A patients with high-titer inhibitors. J Clin Invest 1983; 71: 1836-1841.
2 Hedner U, Glazer S, Pingel K. et al. Successful use of recombinant factor VIIa in patient with severe haemophilia A during synovectomy. Lancet 1988; 2: 1193.
3 Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med 2007; 356: 2301-2311.
4 Hedner U. Mechanism of action of factor VIIa in the treatment of coagulopathies. Semin Thromb Hemost. 2006; 32 (Suppl. 01) 77-85.
5 Ten Cate H, Bauer KA, Levi M. et al. The activation of factor X and prothrombin by recombinant factor VIIa in vivo is mediated by tissue factor. J Clin Invest 1993; 92: 1207-1212.
6 Lisman T, Bijsterveld NR, Adelmeijer J. et al. Re -combinant factor VIIa reverses the in vitro and ex vivo anticoagulant and profibrinolytic effects of fondaparinux. J Thromb Haemost 2003; 1: 2368-2373.
7 Ingerslev J. Efficacy and safety of recombinant factor VIIa in the prophylaxis of bleeding in various surgical procedures in hemophilic patients with factor VIII and factor IX inhibitors. Semin Thromb Hemost 2000; 26: 425-432.
8 Hedner U. Treatment of patients with factor VIII and factor IX inhibitors with special focus on the use of recombinant factor VIIa. Thromb Haemost 1999; 82: 531-539.
9 Hedner U. Recombinant activated factor VII as a universal haemostatic agent. Blood Coagul Fibrinolysis 1998; 9: S147-152.
10 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.
11 Raobaikady R, Redman J, Ball JA. et al. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Br J Anaesth 2005; 94: 586-591.
12 Diprose P, Herbertson MJ, O’Shaughnessy D. et al. Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: randomized double-blind placebo-controlled pilot study. Br J Anaesth 2005; 95: 596-602.
13 Hendriks HG, Meijer K, de Wolf JT. et al. Reduced transfusion requirements by recombinant factor VIIa in orthotopic liver transplantation: a pilot study. Transplantation 2001; 71: 402-405.
14 Planinsic RM, van der MJ, Testa G. et al. Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease. Liver Transpl 2005; 11: 895-900.
15 Lodge JP, Jonas S, Jones RM. et al. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl 2005; 11: 973-979.
16 Lodge P, Jonas S, Jaeck D. et al. Recombinant factor VIIa in partial hepatectomy: A randomized placebo-controlled, double-blind clinical trial. J Hepatol 2003; 36: 177.
17 Kenet G, Walden R, Eldad A. et al. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999; 354: 1879.
18 Martinowitz U, Kenet G, Segal E. et al. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 2001; 51: 431-438.
19 Schreiber MA, Holcomb JB, Hedner U. et al. The effect of recombinant factor VIIa on coagulopathic pigs with grade V liver injuries. J Trauma 2002; 53: 252-257.
20 Schreiber MA, Holcomb JB, Hedner U. et al. The effect of recombinant factor VIIa on noncoagulopathic pigs with grade V liver injuries. J Am Coll Surg 2003; 196: 691-697.
21 Boffard KD, Riou B, Warren B. et al. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma 2005; 59: 8-15.
22 Ranucci M, Isgro G, Soro G. et al. Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials. Arch Surg 2008; 143: 296-304.
23 Von Heymann C, Jonas S, Spies C. et al. Recombinant activated factor VIIa for the treatment of bleeding in major abdominal surgery including vascular and urological surgery: a review and meta-analysis of published data. Crit Care 2008; 12: R14.
24 Aledort LM. Recombinant Factor VIIa is a panhemostatic agent?. Thromb Haemost 2000; 83: 637-638.
25 Levi M. Disseminated intravascular coagulation. Crit Care Med 2007; 35: 2191-2195.
26 Roberts HR. Clinical experience with activated factor VII: focus on safety aspects. Blood Coagul Fibrinolysis 1998; 9: S115-118.
27 Peerlinck K, Vermylen J. Acute myocardial infarction following administration of recombinant activated factor VII (Novo Seven) in a patient with haemophilia A and inhibitor. Thromb Haemost 1999; 82: 1775-1776.
28 Aledort LM. rFVIIa – its thrombogenicity. Thromb Haemost 2000; 84: 522-523.
29 Aledort LM. Comparative thrombotic event incidence after infusion of recombinant factor VIIa versus factor VIII inhibitor bypass activity. J Thromb Haemost 2004; 2: 1700-1708.
30 Levi M, Peters M, Buller HR. Efficacy and safety of recombinant factor VIIa for the treatment of severe bleeding: a systematic review. Crit Care Med 2005; 33: 883-890.
31 Mayer SA, Brun NC, Begtrup K. et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005; 352: 777-785.
32 O’Connell KA, Wood JJ, Wise RP. et al. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293-298.