Evidence-based Emergency Medicine/Critically Appraised Topic. The efficacy of recombinant activated factor VII in severe trauma.
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.


CONCLUSIONS
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.
Nishijima
Daniel K
DK
Department of Emergency Medicine, University of California-Davis Medical Center, Sacramento, CA 95817, USA. daniel.nishijima@ucdmc.ucdavis.edu
Zehtabchi
Shahriar
S
D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004636:Emergency Service, Hospital; D055416:Evidence-Based Emergency Medicine; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D009104:Multiple Trauma / Q000188:drug therapy* / Q000401:mortality* / Q000628:therapy; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
D003029:Coagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa