The Efficacy of Recombinant Activated Factor VII in Severe Trauma.
Nishijima, Daniel K. MD a; Zehtabchi, Shahriar MD b
[Miscellaneous Article] Annals of Emergency Medicine. 54(5):737-744e1, November 2009.

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Study objective: The use of recombinant activated factor VII (rFVIIa) in severe trauma is controversial. This evidence-based emergency medicine review evaluates the existing evidence about the efficacy and safety of rFVIIa for the management of severe trauma.

Methods: We searched MEDLINE, EMBASE, the Cochrane Library, and other databases. We limited our review to prospective, controlled trials that involved the therapeutic use of rFVIIa in the emergency department phase of care. We included studies with blunt and penetrating severe trauma. The primary outcome measure of interest was mortality. Secondary patient-important outcome measures included neurologic outcome, delayed surgical intervention, and adverse effects. Standard criteria were used to evaluate the quality of published trials.

Results: One randomized, blinded trial met the inclusion criteria. There was no significant difference in mortality or adverse effects between rFVIIa and placebo. Our other selected secondary outcome measures of interest were not reported.

Conclusion: Existing evidence suggests that there is no significant difference in mortality between rFVIIa and placebo. Further research is needed to better understand the efficacy and safety of rFVIIa in patients with severe trauma.

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