Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 9
- 主要终点
- New infarcts between baseline and final MRI
研究概览
简要总结
Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SAH (WFNS 1-4)
- •Perfusion relevant CVS
- •Ability for MRI, DSA and intraarterial treatment
排除标准
- •extended cerebral infarcts
- •SAH or ICH from AVM or flow associated aneurysm
- •Non aneurismal SAH
- •Relevant non spastic stenosis of brain supplying arteries
结局指标
主要结局
New infarcts between baseline and final MRI
时间窗: 21 + - 7 days
次要结局
- Clinical outcome (mRS, Karnofsky)(6 months)
