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Most clotting-factor concentrates are designed to replace deficient coagulants and enhance physiologic hemostasis. When bleeding is life threatening, activating the coagulation system pharmacologically with potent procoagulants might be necessary. However, use of these agents can be associated with occlusive vascular thrombi and end-organ ischemia. Recombinant activated factor VII (rFVIIa) controls hemorrhage effectively in a variety of clinical situations, but the risk for thromboembolic (TE) complications is not well understood.
To better characterize this potential risk, investigators (some affiliated with the manufacturer of rFVIIa) analyzed data from 4468 patients in 35 randomized, placebo-controlled trials that focused on off-label use…