作者
Charles V Pollack Jr, Paul A Reilly, Joanne Van Ryn, John W Eikelboom, Stephan Glund, Richard A Bernstein, Robert Dubiel, Menno V Huisman, Elaine M Hylek, Chak-Wah Kam, Pieter W Kamphuisen, Jörg Kreuzer, Jerrold H Levy, Gordon Royle, Frank W Sellke, Joachim Stangier, Thorsten Steiner, Peter Verhamme, Bushi Wang, Laura Young, Jeffrey I Weitz
发表日期
2017/8/3
期刊
New England Journal of Medicine
卷号
377
期号
5
页码范围
431-441
出版商
Massachusetts Medical Society
简介
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.
Results
A total of 503 patients were enrolled: 301 in group A, and 202 in group B. The median maximum percentage reversal of dabigatran was 100% (95% confidence interval, 100 to 100), on the …
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CV Pollack Jr, PA Reilly, J Van Ryn, JW Eikelboom… - New England Journal of Medicine, 2017