title: Current evidence based guidelines for factor VIIa use in trauma: the good, the bad, and the ugly.
abstract: Recombinant factor VII (rFVIIa) has arisen as an option for the control of life-threatening traumatic bleeding unresponsive to other means. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and risk/benefits ratio are presently poorly defined. A Medline search from 1995 through March 2008 was conducted. All English language articles containing the terms "trauma" and "factor VII" or its variants were retrieved. Letters to the editor, animal studies, and general reviews were excluded. A total of 19 articles met inclusion criteria. These articles were then reviewed and stratified into three classes of evidence according to the quality assessment instrument developed by the Brain and Trauma Foundation. Levels of recommendation were developed. A total of 118 articles were identified. Only one Class I study was identified. This study demonstrated that three doses of rFVIIa given in blunt traumatic hemorrhage yielded a significant reduction of 2.6 of red blood cells used. These findings were not statistically significant for penetrating trauma patients. There was no reduction in mortality and no increase in thromboembolic events. Four Class II studies were identified; three showed a significant decrease of blood product usage and one demonstrated significant reductions in 24-hour and 30 day death from hemorrhage in patients receiving rFVIIa. The remaining 14 studies were Class III reviews of databases, registries, case series, and case reports. No identified study specifically addressed the cost/benefit analysis of rFVIIa usage in trauma hemorrhage. Utility of rFVIIa in trauma-associated hemorrhage remains controversial. There is Level I supporting the use of rFVIIa for blunt trauma patients only. There is no Class I evidence supporting decreased mortality or differences in thromboembolic events. Minimal effective dosing regimens and cost/benefit analyses have not yet been examined.
authors.affiliation: Department of Surgery, Tulane School of Medicine, New Orleans, Louisiana 70112-2699, USA. jduchesn@tulane.edu
authors.forename: Juan C
authors.initials: JC
authors.lastname: Duchesne
authors.forename: Kavitha A
authors.initials: KA
authors.lastname: Mathew
authors.forename: Alan B
authors.initials: AB
authors.lastname: Marr
authors.forename: Michael R
authors.initials: MR
authors.lastname: Pinsky
authors.forename: James M
authors.initials: JM
authors.lastname: Barbeau
authors.forename: Norman E
authors.initials: NE
authors.lastname: McSwain
mesh_terms: D003029:Coagulants / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D015942:Factor VIIa / Q000627:therapeutic use*; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D017410:Practice Guidelines as Topic; D011994:Recombinant Proteins / Q000627:therapeutic use; D015599:Trauma Severity Indices; D014947:Wounds and Injuries / Q000150:complications*
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa