EUCTR2017-000429-10-FR进行中（未招募）1 期
FIVHeMA: Intraventricular fibrinolysis versus external ventricular drainage alone in aneurysmal subarachnoid hemorrhage: a randomized controlled trial. - FIVHEMA
CHU CAE0 个研究点目标入组 440 人开始时间: 2017年9月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
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
- •- Patients (age 18-75) with SAH on initial CT-Scan examination.
- •- SAH associated with hydrocephalus requiring external ventricular drainage.
- •- Confirmation of an associated intracranial aneurysm by vascular imaging.
- •- Time from onset to admission under 24 hours.
- •- Exclusion of the aneurysm by surgical clipping or endovascular coiling before IVF.
- •- Oral information on research and informed consent of the patient and/or his relatives.
- •- Patients affiliated to the French Social Security.
- •- Patients speaking French fluently.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 440
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 440
排除标准
- •- Patient with severe clinical presentation on admission: WFNS score = 5.
- •- Associated intracerebral hematoma of more than 2 cm in its larger width.
- •- SAH diagnosed on lumbar puncture: original Fisher grade = 1.
- •- Impossibility to exclude the aneurysm within 72 hours following its rupture.
- •- Patient previously treated with antiplatelet therapy or treated with antiplatelet therapy after the aneurysm exclusion.
- •- Severe coagulopathy, including oral vitamin K antagonist.
- •- Pregnant or lactating woman.
研究者
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