Recombinant factor VIIa: review of current "off license" indications and implications for practice.

Uncontrolled bleeding and coagulopathy are associated with trauma, liver failure, obstetric conditions, and a variety of surgical circumstances, resulting in increased morbidity and mortality in the critically ill. Recently, the role of recombinant factor VIIa (rFVIIa) in the management of uncontrolled bleeding has attracted interest. rFVIIa was initially developed (and licensed) for the treatment of hemophilia. Increasingly, evidence suggests rFVIIa causes cessation of bleeding, improves coagulation markers, and reduces blood product use for treatment of severe bleeding due to other causes. The majority of evidence for nonlicensed use of rFVIIa consists of case reports. Recently, the first randomized controlled trial of rFVIIa in trauma patients reported a significant reduction in red blood cell transfusion, and a trend toward reduced mortality and critical complications. As evidence builds to support the use of rFVIIa, nurses need to be aware of the administration and safety issues of this treatment.