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Traumatic hemorrhage can cause early mortality via exsanguination and late mortality through sepsis and multiorgan system failure. In a randomized, controlled, double-blind study in 26 countries, researchers evaluated the efficacy and safety of recombinant activated factor VII (rFVIIa) in adult trauma patients with torso or lower-extremity hemorrhage after receipt of four to eight units of packed red blood cells (RBCs). Patients who were moribund or had severe brain injury were excluded. Overall, 481 patients with blunt trauma and 92 with penetrating trauma were randomized to receive three doses of rFVIIa or placebo starting within 12 hours after injury. The study was supported by the manufacturer of rFVIIa.
All-cause 30-day mortality (the p…