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

Abstract

Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular injury makes it an attractive potential treatment for massive, uncontrolled bleeding associated with surgery and trauma. This article describes the evidence relating to surgery and trauma. The lack of large, controlled trials of rFVIIa means that a definitive recommendation regarding its use cannot be made at present. However, in the context of clearly defined protocols and balanced treatment strategies, rFVIIa may have a role in traumatic bleeding. Large scale, randomised controlled trials in trauma are required, as is further work on the safety profile of rFVIIa with an independent international safety monitoring committee.

• Authors: Stephen J Wilson, Mark C Bellamy, Peter V Giannoudis
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 4 Issue 3 Pg. 557-70 (May 2005) ISSN: 1744-764X [Electronic] England
• PMID: 15934860 (Publication Type: Journal Article, Review)

Chemical References

• Factor VIIa

Topics

• Drug Costs
• Drug Interactions
• Factor VIIa (adverse effects, pharmacology, therapeutic use)
• Hemorrhage (drug therapy, etiology)
• Humans
• Randomized Controlled Trials as Topic
• Safety
• Surgical Procedures, Operative (adverse effects, methods)
• Wounds and Injuries (complications, surgery)