NCT00154427终止2 期
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 64
- 主要终点
- Incidence of critical, serious adverse events
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).
The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-operative bleeding according to pre-defined criteria for critical bleeding
排除标准
- 未提供
结局指标
主要结局
Incidence of critical, serious adverse events
时间窗: Within 30 days
次要结局
- Surgical drainage volume(For the duration of the trial)
- Amount of transfusions(For the duration of the trial)
研究者
研究点 (64)
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