The rational use of recombinant factor VIIa in the treatment of major intractable bleeding in the trauma patient

Abstract

Background: The off-label use of recombinant factor VIIa (rFVIIa / Eptacog Alfa/NovoSeven®) in trauma patients with massive haemorrhage has increased since 1999. Some clinicians see its role as a prophylactic drug to prevent major blood loss, while others use it as a rescue drug in life-threatening haemorrhage. There has been much debate regarding its clinical application, effectiveness, thromboembolic potential and cost/benefit ratio. A literature review was done to attempt to clarify some of these issues. Methods: An electronic literature search of Medline and Pubmed databases was conducted applying keywords: NovoSeven, rFVIIa, recombinant FVIIa, Eptacog Alfa, trauma, major blood loss. Results: rFVIIa has been used off-label in a variety of clinical settings either to prevent blood loss, or to treat intractable major haemorrhage. This includes several case reports and cohort studies in the trauma setting. Unfortunately there are only two randomised clinical trials (RCT) available regarding the use of rFVIIa in trauma. These RCTs were small and did not show significant benefit in favour of rFVIIa. There is still not sufficient level 1 evidence to support the routine use of rFVIIa in trauma patients, either prophylactically or as first line treatment for major haemorrhage. It also seems that the drug has a higher potential to cause thromboembolic complications than initially reported. It is very expensive and therefore has an unfavourable cost/benefit ratio. In the absence of good evidence of benefit, expert opinion regards rFVIIa as drug to be used only in life-threatening major haemorrhage where conventional treatment has failed.