Prophylactic Use of Intrathecal Calcium Channel Antagonist Through Lumbar Drain in Patients With Subarachnoid Hemorrhage Due to Aneurysmal Rupture
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Incidence of Vasospasm
研究概览
简要总结
The purpose of this study is to determine the effectiveness of prophylactic administration of intra-thecal nicardipine though lumbar cerebrospinal fluid drain in prevention of symptomatic vasospasm in patients with subarachnoid hemorrhage due to rupture of cerebral aneurysms.
详细描述
This is a triple-blinded, prospective, sham, randomized study. The purpose of this research is to determine the effectiveness of prophylactic administration of intra-thecal nicardipine though lumbar cerebrospinal fluid drain in prevention of symptomatic vasospasm in patients with subarachnoid hemorrhage due to rupture of cerebral aneurysms. Patients will be randomized to standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine vs standard treatment alone. The medication used is FDA approved and will be used through an intra-thecal route through a lumbar drain which is indicated in patients with subarachnoid hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, 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
- •Age ≥18 years
- •Aneurysmal subarachnoid hemorrhage with Hunt and Hess score 3 or less
- •Patient or legal authorized representative available to sign the informed consent form
- •Pre-morbid modified Rankin scale of 0 or
- •Patients who have lumbar drain placed or planned for cerebrospinal fluid diversion per standard of care
- •Patients who are able to be randomized within 72 hours from arrival with aneurysmal subarachnoid hemorrhage or within 24 hours from lumbar drain placement
排除标准
- •Pregnant females
- •Subarachnoid hemorrhage (SAH) with hunt and hess scale of >3
- •SAH due to etiology other than aneurysmal rupture
- •Any contraindications in patients receiving calcium channel antagonists like hypersensitivity to dihydropyridines
- •Active central nerve infection (CNS) infection or high suspicion of CNS infection
- •Hemodynamic instability preventing the use of Nicardipine
研究组 & 干预措施
Standard of Care Plus Nicardipine
standard treatment of cerebral vasospasm with prophylactic administration of intrathecal nicardipine
干预措施: Nicardipine (Drug)
Standard of Care
standard treatment of cerebral vasospasm and sham injection of 10 mL preservative-free normal saline in luer-lock sterile syringe
干预措施: Normal Saline (Drug)
结局指标
主要结局
Incidence of Vasospasm
时间窗: up to hospitalization day 21
The incidence of symptomatic clinical or radiographic vasospasm in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
Incidence of Delayed Cerebral Ischemia
时间窗: up to hospitalization day 21
The incidence of symptomatic clinical or radiographic delayed cerebral ischemia in patients treated with prophylactic administration of intrathecal nicardipine though lumbar drain
次要结局
- Modified Rankin Scale Score(month 6)
- Incidence of Meningitis(up to hospitalization day 21)