Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 28
- 主要终点
- Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6
研究概览
简要总结
To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.
详细描述
Objective:
To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.
Design:
This study is a multi-center, prospective, double-blinded, randomized controlled trial.
Interventions:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The assigned "intervention" will be performed only by a separate unblinded dedicated physician who signs the confidential agreement. The attending/investigating physician and patient are blinded to the intervention assignment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intrathecal Treatment Group
The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
干预措施: Intrathecal Nicardipine (Drug)
Control Group
The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.
干预措施: No intervention (Other)
结局指标
主要结局
Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6
时间窗: Day 90±30, Day 365±60.
The percentage of patients with mRS 0-2
次要结局
- Extended Glasgow Outcome Score (GOS-E).(Day 90±30, Day 365±60.)
- Modified Rankin Scale ordinal shift with mRS 5 and 6 combined(Day 90±30, Day 365±60.)
- Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6(Day 90±30, Day 365±60.)
- Mini-Mental State Examination (MMSE) score(Day 90±30, Day 365±60.)
- Change of National Institutes of Health Stroke Scale (NIHSS) score(At discharge)
- Cerebrospinal fluid shunt surgery rate(Day 90±30, Day 365±60.)
- Overall mortality rate(Day 90±30, Day 365±60.)
- Rate of CSF infection(Day 30±7)
- Rate of any type of new intracranial hemorrhage.(Day 90±30, Day 365±60.)
- Adverse Event(Baseline, Day 2-21, Day 90±30, Day 365±60.)
- Serious Adverse Event(Baseline, Day 2-21, Day 90±30, Day 365±60.)
研究者
Zeguang Ren
Principal Investigator
The Affiliated Hospital Of Guizhou Medical University