Transfusion Medicine Reviews
Volume 22, Issue 3 , Pages 177-187 , July 2008

Evidence for the Use of Recombinant Factor VIIa in the Prevention and Treatment of Bleeding in Patients Without Hemophilia

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. Hoffman M, Monroe DM. A cell-based model of hemostasis. Thromb Haemost. 2001;85:958–965
  4. Roberts HR, Monroe DM, White GC. The use of recombinant factor VIIa in the treatment of bleeding disorders. Blood. 2004;104:3858–3864
  5. Carr ME, Martin EJ. Recombinant factor VIIa: Clinical applications for an intravenous hemostatic agent with broad-spectrum potential. Expert Rev Cardiovasc Ther. 2004;2:661–674
  6. Martinowitz U, Holcomb JB, Pusateri AE, et al. Intravenous rFVIIa administered for hemorrhage control in hypothermic coagulopathic swine with grade V liver injuries. J Trauma. 2001;50:721–729
  7. Kenet G, Walden R, Eldad A, et al. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet. 1999;354:1879
  8. Grounds RM, Bolan C. Clinical experiences and current evidence for therapeutic recombinant factor VIIa treatment in nontrauma settings. Crit Care. 2005;9(Suppl 5):S29–S36
  9. Hoots K. Challenges in the therapeutic use of a “so-called” universal hemostatic agent: Recombinant factor VIIa. Hematol Am Soc Hematol Educ Program. 2006;426–431
  10. Steiner ME, Key NS. Use of recombinant activated factor VII in the management of medical and surgical bleeding: A critical review. Transfus Alternatives Transfus Med. 2006;8(Suppl 1):66–80
  11. Weiskopf RB. Recombinant-activated coagulation factor VIIa (NovoSeven): Current development. Vox Sang. 2007;92:281–288
  12. Stanworth SJ, Birchall J, Doree CJ, et al. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Syst Rev. 2007;2:CD005011
  13. Mathew P. The use or rFVIIa in non-haemophilia bleeding contitions in paediatrics: A systematic review. Thromb Haemost. 2004;92:738–746
  14. Levi M, Peters M, Büller HR. Efficacy and safety or recombinant factor VIIa for treatment of severe bleeding: A systematic review. Crit Care Med. 2005;33:883–890
  15. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–412
  16. Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323:42–46
  17. 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;59:8–18
  18. Jeffers L, Chalasani N, Balart L, et al. Safety and efficacy of recombinant factor VIIa in patients with liver disease undergoing laparoscopic liver biopsy. Gastroenterology. 2002;123:118–126
  19. 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
  20. Lodge JP, Jonas S, Oussoultzoglou E, et al. Recombinant coagulation factor VIIa in major liver resection: A randomized, placebo-controlled, double-blind clinical trial. Anesthesiology. 2005;102:269–275
  21. Shao YF, Yang JM, Chau GY, et al. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: A multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg. 2006;191:245–249
  22. 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
  23. Planinsic RM, van der Meer J, 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
  24. Bowles KM, Callaghan CJ, Taylor AL. Predicting response to recombinant factor VIIa in non-haemophiliac patients with severe haemorrhage. Br J Anaesth. 2006;97:476–481
  25. Raobaikady R, Redman J, Ball JA, et al. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery or traumatic fracture of pelvis or pelvis and acetabulum: A double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2005;94:586–591
  26. 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
  27. Ekert H, Brizard D, Eyers R, et al. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: A randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis. 2006;17:389–395
  28. Bosch J, Thabut D, Bendtsen F, et al. Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: A randomized, double-blind trial. Gastroenterology. 2004;127:1123–1130
  29. Chuansumrit A, Wangruangsatid S, Lektrakul Y, et al. Control of bleeding in children with dengue hemorrhagic fever using recombinant activated factor VII: A randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis. 2005;16:549–555
  30. Mayer SA, Brun NC, Broderick J, et al. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke. 2005;36:74–79
  31. Mayer SA, Brun NC, Broderick J, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. US phase IIA trial. Neurocrit Care. 2006;4:206–214
  32. Pihusch M, Bacigalupo A, Szer J, et al. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005;3:1935–1944
  33. Mayer SA, Brun NC, Begtrup K, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005;352:777–785
  34. Vincent JL, Rossaint R, Riou B, et al. Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding—A European perspective. Crit Care. 2006;10:R120;(1-12)
  35. MacLaren R, Weber LA, Brake H, et al. A multicenter assessment of recombinant factor VIIa off-label usage: Clinical experiences and associated outcomes. Transfusion. 2005;45:1434–1442
  36. Biss TT, Hanley JP. Use of recombinant activated factor VII in the management of intractable haemorrhage: A survey of current UK practice. Br J Haematol. 2007;138:126–128
  37. Goodnough LT, Lublin DM, Zhang L, et al. Transfusion medicine service policies for recombinant factor VIIa administration. Transfusion. 2004;44:1325–1331
  38. Martinowitz U, Michaelson M. Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: A report by the Israeli Multidisciplinary rFVIIa Task Force. J Throm Haemost. 2005;3:640–648
  39. Roberts HR. Recombinant factor VIIa: A general hemostatic agent? Yes. J Thromb Haemost. 2004;2:1691–1695
  40. Dzik WH. Off-label reports of new biologics: Exciting new therapy or dubious research? Examples from recombinant activated factor VII. J Intensive Care Med. 2006;21:54–57
  41. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PloS Med. 2006;2:e138
  42. Webert KE, Blajchman MA. Randomized trials in patients with blunt and penetrating trauma. J Trauma. 2006;60:242–243(letter)
  43. Ho AM, Karmakar MK, Dion PW. Are we giving enough coagulation factors during major trauma resuscitation?. Am Journal Surg. 2005;190:479–484
  44. Mayer SA on behalf of the FAST Trial Steering Committee. Complications in patients with intracerebral hemorrhage treated with recombinant factor VIIa. Neurology. 2007;69:319–320(letter)
  45. 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
  46. Thomas GO, Dutton RP, Hemlock B, et al. Thromboembolic complications associated with factor VIIa administration. J Trauma. 2007;62:564–569
  47. Spahn DR, Tucci MA, Makris M. Is recombinant FVIIa the magic bullet in the treatment of major bleeding?. Br J Anaesth. 2005;94:553–555
  48. Lusher JM. Early treatment with recombinant factor VIIa results in greater efficacy with less product. Eur J Haematol Suppl. 1998;61:7–10
  49. Key NS. Recombinant FVIIa for intractable hemorrhage: more questions than answers. Transfusion. 2003;43:1649–1651
  50. Hillman J, Fridriksson S, Nilsson O, et al. Immediate administration of tranexamic acid and reduced incidence of early rebleeding after aneurysmal subarachnoid hemorrhage: a prospective randomized study. J Neurosurg. 2002;97:771–778

 Acknowledgements of research support: National Health Service Blood & Transplant, UK.

PII: S0887-7963(08)00012-6

doi: 10.1016/j.tmrv.2008.02.007

Transfusion Medicine Reviews
Volume 22, Issue 3 , Pages 177-187 , July 2008