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Idarucizumab is a monoclonal antibody fragment that specifically binds to dabigatran and reverses its anticoagulant activity. A preliminary trial demonstrating safety and effectiveness led to its FDA approval in October 2015 (NEJM JW Oncol Hematol Aug 2015). The investigators now present the final results of their industry-sponsored, multicenter, open-label study involving 503 patients (median age, 78 years) who required reversal of dabigatran; 202 were about to undergo urgent invasive procedures, and 301 had uncontrollable or life-threatening bleeding; most hemorrhages were gastrointestinal or intracranial. Patients received two intravenous bolus doses of idarucizumab (2.5 g) no more than 15 minutes apart.
A prolonged diluted thrombin time …