title: Life, limb or off-label recombinant VIIa use in the setting of limited blood assets: a case study.
abstract: Due to the lack of adequate controlled trials, the off-label use of recombinant factor VIIa (rFVIIa) to control hemorrhage in trauma patients remains controversial. The decision regarding when to initiate rFVIIa therapy is particularly problematic. Whereas most reports and trials have delayed use until significant bleeding has occurred, there is some evidence that coagulopathy develops early in some trauma patients, raising the possibility that early rFVIIa use may be more clinically efficacious. Herein, we report the case of a hemodynamically unstable patient with massive blood loss from multiple gunshot wounds and who had a potentially salvageable upper extremity. Rapid hemorrhage despite efforts to surgically control the bleeding resulted in virtual exhaustion of the facilities' limited blood component supply. Hemorrhage was controlled when rFVIIa was added to hypotensive resuscitation allowing salvage of the arm and significant conservation of blood products. This case raises the question as to whether earlier off-label use of this agent should be considered when amputation for hemorrhage control is being considered and/or conservation of limited blood assets is needed.
authors: Pfizer, Inc., Collegeville, PA 18966, USA. mecarrjr@msn.com
authors: Marcus E
authors: ME
authors: Carr
authors: Brian
authors: B
authors: Vickaryous
mesh_terms: D000328:Adult; D001803:Blood Transfusion; D015942:Factor VIIa / Q000627:therapeutic use*; D006470:Hemorrhage / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D023821:Limb Salvage; D008297:Male; D056687:Off-Label Use; D011994:Recombinant Proteins / Q000627:therapeutic use; D016879:Salvage Therapy; D014948:Wounds, Gunshot / Q000097:blood / Q000188:drug therapy*
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa