Response to letter regarding article, "Management and outcomes of major bleeding during treatment with dabigatran or warfarin".

We thank Hifumi et al for their comments on our article.1 It is important to recognize that treatment of major bleeding on warfarin in the 5 phase III trials was according to local hospital guidelines and protocols, which are generally based on international recommendations.2 The low reversal rate of warfarin is surprising but reflects the way warfarin-associated bleeding was managed at the emergency departments where these patients were seen. We were able to capture information on treatment with blood products or any coagulation factor concentrates accurately because such information was available both from transfusion journals, case report forms, and adverse event narratives. It is however possible that treatment with vitamin K as well as repeated dosing were underreported, including for patients in the intensive care units (ICU), as …