articleNew England Journal of MedicineJul 11, 2017BRONZE OA

Idarucizumab for Dabigatran Reversal — Full Cohort Analysis

Boehringer Ingelheim (Germany) · Heidelberg University · +17 more institutions

PubMed
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Abstract

Background

Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran.

Methods

We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time. Secondary end points included the restoration of hemostasis and safety measures.

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