NCT00930072终止2 期
Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
研究概览
简要总结
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
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
- Double (Care Provider, 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
- •High grade spontaneous SAH (Fisher Grade III and IV)
- •Secured aneurysm (clipped/coiled)
- •Evidence of severe vasospasm - MCA mean flow velocity >200 cm/sec and Lindegaard ratio >6 OR Symptomatic vasospasm with either angiographic evidence (no angioplasty), or at least moderate severity according to TCD criteria (MCA mean flow velocity >150 cm/sec and Lindegaard ratio >3, or ACA vasospasm)
排除标准
- •Allergy to local anesthetic or contrast
- •Coagulation disorders with PT <70%, or INR >1.4, or PTT >1.5 times control and/or platelets <70,000x106/L
- •Use of enoxaparin within 12 hours
- •Use of clopidogrel within 7 days
- •Use of coumadin within 5 days
- •Use of ticlopidine within 14 days
- •Use of intravenous thrombolytics within 10 days
- •Any use of hirudin derivatives during ICU stay
研究组 & 干预措施
Block
Experimental
干预措施: Cervical Sympathetic Block (bupivicaine, clonidine) (Drug)
结局指标
主要结局
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Miriam Treggiari
Professor
University of Washington
研究点 (1)
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