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Expert Opinion on Drug Safety Volume 4, 2005 - Issue 3
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Review

The safety and efficacy of the administration of recombinant activated factor VII in major surgery and trauma patients

Stephen J WilsonSt James’s University Hospital Intensive Care Unit, Leeds LS9 7TFUK
,
Mark C BellamySt James’s University Hospital Department of Trauma, Leeds LS9 7TFUKE-mail: [email protected]
&
Peter V GiannoudisSt James’s University Hospital Intensive Care Unit, Leeds LS9 7TFUK
Pages 557-570 | Published online: 10 May 2005

Bibliography

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  • ••Part of a series of lectures sponsored byNovo Nordisk. A good presentation of basic science.
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  • ••A very concise and well-referenced reviewarticle, covering most aspects of surgery and trauma.
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  • ••Large, RCT of rFVIIa in liver surgery.
  • JEFFERS L, CHALASANI N, BALART L, PYRSOPOULOS N, ERHARDTSEN E: Safety and Efficacy of Recombinant Factor VIIa in Patients With Liver Disease Undergoing Laparoscopic Liver Biopsy. Gastroenterology (2002) 123:118–126
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  • PAVESEP, BONADONA A, BEAUBIEN Jet al.: FVIIa corrects the coagulopathy of fulminant hepatic failure but may be associated with thrombosis: a report of four cases. Can. J. Arresth. (2005) 52:56–59
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  • •Small, RCT of rFVIIa in prostate surgery.
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  • ••Large, multicentre, RCT of rFVIIa inupper gastrointestinal bleeding. Partially funded by Novo Nordisk.
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  • ••Large, multicentre, RCT, partiallysponsored by Novo Nordisk.
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  • •The first published use of rFVIIa In a trauma patient.
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  • ••A large, randomised, placebo-controlledstudy of rFVIIa in trauma patients. Conducted by the NovoSeven® trauma research group.
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  • •A smaller, randomised, placebo-controlled study of rFVIIa In trauma patients. Conducted by the NovoSeven® trauma research group.
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  • SCHREIBER M, HOLCOMB J, 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.
  • JEROUKHIMOV I, JEWELEWICZ D, ZAIAS J et al: Early injection of high-dose recombinant Factor VIIa decreases blood loss and prolongs time from injury to death in experimental liver injury. Trauma (2002) 53:1053–1057.
  • FATTORUTTO M, TOURREAU-PHAM S, MAZOYER E et al.: Recombinant activated Factor VII decreases bleeding without increasing arterial thrombosis in rabbits. Can. J. Arraesth. (2004) 51:672–679.
  • ERHARDTSEN E: Ongoing NovoSeven®trials. Intensive Care Med. (2002) 28:S248–S255.
  • •A useful review of currently ongoing trials with rFVIIa. The author is employed by Novo Nordisk.
  • LINDHOUT T, FRANSSEN J, WILLEMS G: Kinetics of the inhibition of tissue factor-factor VIIa by tissue factor pathway inhibitor. Thromb. Haemost. (1995) 74:910–915.
  • ROBERTS H, MONROE D, HOFFMAN M: Safety profile of recombinant Factor VIIa. Semia Hematol (2004) 41(Suppl.e 1):101–108.
  • •A useful review of the safety of rFVIIa, Including the most recent evidence from its use in haemophilia.
  • GUILLET B, PINGANAUD C, PROULLE V et al.: Myocardial infarction occurring in a case of acquired haemophilia during the treatment course with recombinant activated Factor VII. Thromb. Haemost (2002) 88:698–699.
  • D'OIRON R, MENART C, TRZECIAK M et al.: Use of recombinant Factor VIIa in 3 patients with Glanzmanffs thrombasthenia undergoing invasive procedures. Thromb. Haernost. (2000) 83:644–647.
  • •A useful review of safety issues in patients with coagulation factor deficiencies.
  • ABSHIRE T, KENET G: Recombinant Factor VIIa: a review of efficacy, dosing regimens and safety in patients with congenital and acquired Factor VIII or IX inhibitors. Thromb. Haernost. (2004) 2:899–909
  • CLARK A, GORDON W WALKER I, TAIT R: last-ditch' use of recombinant Factor VIIa in patients with massive haemorrhage is ineffective. Vox. Sang. (2004) 86:120–124.

Websites

  • http://www.who.int/inffen/pr-2002–39.html. World Health Organisation press release: Preventing death and disability due to injuries is both an economic imperative and a health priority (2002).

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