The Intra-arterial Vasospasm Trial - A Multi-center Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- Post Infusion Improvement Ratio (PIIR)
研究概览
简要总结
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.
We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy.
All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved.
详细描述
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.
This study is a prospective multicenter randomized trial. The primary outcome measure is the Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post intra-arterial drug infusion in the presenting vasospasmic blood vessel.
Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a secondary outcome to assess clinical outcome.
The interventions in this study are a part of routine standard of care (SOC) procedures for cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal medical management, endovascular treatment by intra-arterial drug infusion of single drug agent or cocktail drug agents will be initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.
- •Symptomatic vasospasm (clinical or TCD)
- •For centers that perform a routine day 7 angiogram post-aneurysm treatment - 50% or more stenosis seen on diagnostic angiogram for asymptomatic patients.
排除标准
- •Inability to obtain consent from patient or patients kin
- •Pregnant women
- •less than 18 years of age of more than 80 years of age
- •Hunt Hess Grade 5 SAH
- •Intra-arterial drug treatment in all 3 arterial territories
研究组 & 干预措施
Nicardipine
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
干预措施: Nicardipine (Drug)
Verapamil
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
干预措施: Verapamil (Drug)
Nicardipine + Verapamil + Nitroglycerin
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
干预措施: Nicardipine + Verapamil + Nitroglycerin (Drug)
结局指标
主要结局
Post Infusion Improvement Ratio (PIIR)
时间窗: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion
Post infusion improvement ratio (PIIR) = ((B - A) / A) \*100 A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter
次要结局
- Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score(3 months post discharge from hospital)
研究者
Peng Roc Chen, MD
Professor in Neurosurgery
The University of Texas Health Science Center, Houston