An industry sponsored placebo-controlled multicentre randomised controlled trial has shown no mortality reduction from recombinant activated Factor VII (rFVIIa) in patients with trauma.
rFVIIa acts physiologically by enhancing clot formation in the presence of tissue factor expressed on injured or ischemic vascular subendothelium. It also acts pharmacologically, binding directly to activated platelets, increasing thrombin burst, and promoting the formation of a stable hemostatic plug.
Blunt and/or penetrating trauma patients aged 18 years to 70 years were eligible if they had continuing torso and/or proximal lower extremity bleeding after receiving 4 units of RBCs despite standard hemostatic interventions. There was no 30 day mortality reduction, although fewer blood products were transfused from dosing to 24 hours in the rFVIIa group.
No significant difference was seen in the safety profile of rFVIIa compared with placebo.
The CONTROL trial was terminated early (573 of 1502 patients) after an interim analysis suggested a high likelihood of futility in demonstrating the primary endpoint in the blunt trauma population.
Results of the CONTROL Trial: Efficacy and Safety of Recombinant Activated Factor VII in the Management of Refractory Traumatic Hemorrhage
Journal of Trauma-Injury Infection & Critical Care September 2010 69(3):489-500
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