NCT01447095已完成2 期
Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Radiographic vasospasm measured by CT perfusion
研究概览
简要总结
The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •SAH verified by CT
- •Aneurysm identified and treated
- •Fisher grade 3 + 4
- •WFNS grade 1-4 (World Federation of Neurosurgical Societies )
排除标准
- •Pregnancy/lactation
- •Heard failure
- •Kidney failure
- •Liver failure
- •Hemorrhagic diathesis
研究组 & 干预措施
High dose prostacyclin
Active Comparator
干预措施: Prostacyclin 2 ng/kg/min (Drug)
Low dose prostacyclin
Active Comparator
干预措施: Prostacyclin 1 ng/kg/min (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Radiographic vasospasm measured by CT perfusion
时间窗: Day 8 (+/- 1 day) after aneurysm treatment
Changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery
次要结局
- Cerebral metabolism measured by microdialysis(every 2. hour day 3-10 after aneurysm treatment)
- Clinical vasospasm(day 5-10 after SAH)
- Glasgow outcome scale (GOS) at 3 months(3 months efter SAH)
- Radiographic vasospasm measured by CT angiography(Measured day 8 +/- 1 day)
- Brain tissue oxygen (PtiO2)(continuous measurement day 3-10 after SAH)
- Mean arterial pressure (MAP)(Continuous day 1-10 after SAH)
- Level of brain damage biomarker(daily day 4-11 after SAH)
研究者
Rune Rasmussen
MD, Sponsor-Investigator
Rigshospitalet, Denmark
研究点 (1)
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