NCT00426803已完成2 期
Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 16
- 主要终点
- Reducing haematoma growth
研究概览
简要总结
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.
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
- •Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom
排除标准
- •Patients with secondary ICH
- •Pre-existing disability
- •Haemophilia
结局指标
主要结局
Reducing haematoma growth
次要结局
- Reducing disability and improving clinical outcome
研究者
研究点 (16)
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