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临床试验/NCT01400360
NCT01400360Unknown不适用

Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage

Johann Wolfgang Goethe University Hospital9 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2009年8月1日最近更新:
适应症

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

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)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other

研究点 (9)

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