Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 6
- 主要终点
- VP-shunt implantation, all-cause mortality, or EVD-related infection.
研究概览
简要总结
The DRAIN trial is an international multi-centre, 1:1 randomised, parallel-group, superiority clinical trial investigating gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aSAH.
The primary objective is to investigate the beneficial and harmful effects of gradual weaning versus prompt closure of EVD treatment in patients with aSAH.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention with two arms with different time course it is not possible to mask patients nor investigators or care providers
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
VP-shunt implantation, all-cause mortality, or EVD-related infection.
时间窗: 6 months after ictus
The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection.
次要结局
- Health-related quality of life (EQ-5D-5L)(6 months after ictus)
- Number of serious adverse events (SAE) not including death(6 months after ictus)
研究者
Tiit Mathiesen
Principal investigator
Rigshospitalet, Denmark