(Protocol No. 1321.3):A Phase III, case series clinical study of the reversal of the anticoagulanteffects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolledbleeding or require emergency surgery or procedures. - REVERSE-AD

Boehringer Ingelheim0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Patients taking dabigatran are eligible for this study if they meet the following criteria:
•1. Overt bleeding judged by the physician to require a reversal agent.
•2. Currently taking dabigatran etexilate.
•3. Age >= 18 years at entry.
•4. Written Informed consent.
•1. A condition requiring emergency surgery or procedure where adequate hemostasis is
•required. Emergency is defined as within the next 4 hours.
•2. Currently taking dabigatran etexilate.
•3. Age >= 18 years at entry.
•4. Written Informed consent.

•1. Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with
•standard supportive care.
•2. Patients with no clinical signs of bleeding.
•3. Contraindications to study medication including known hypersensitivity to the drug or
•its excipients.
•1. A surgery or procedure which is elective or where the risk of uncontrolled or
•unmanageable bleeding is low.
•2. Contraindications to study medication including known hypersensitivity to the drug or
•its excipients.

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