EUCTR2013-004813-41-AT进行中（未招募）1 期
A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0 g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Group A (Bleeding patients)
- •-- Overt bleeding judged by the physician to require a reversal agent
- •-- Currently taking dabigatran etexilate
- •-- At least 18 years of age
- •-- Written informed consent
- •- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or invasive procedure for a condition other than bleeding)
- •-- Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
- •-- Current treatment with dabigatran
- •-- At least 18 years of age
- •-- Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •- Group A (Bleeding Patients)
- •-- Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care
- •-- Patients with no clinical signs of bleeding
- •-- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
- •- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or invasive procedure for a condition other than bleeding)
- •-- A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
- •-- Contraindications to study medication including known hypersensitiity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
研究者
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