High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt.
Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.
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
- None
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
- •Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
- •SAH is suspected to be aneurysmal in source
- •Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage
排除标准
- •Age < 18 years
- •SAH of traumatic or non-aneurysmal etiology
- •Patients treated with lumbar drains
- •EVD placement ≥ 3 days after suspected time of hemorrhage
- •Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
- •Pre-morbid mRS ≥ 3
- •EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)
研究组 & 干预措施
High volume CSF diversion
The EVD will be set to an initial level of 5 mmHg. The drain will remain in place at a level of ≤ 5 mmHg until at least day 10 after SAH before a weaning trial is attempted.
干预措施: CSF Diversion (Procedure)
Conventional CSF diversion
The EVD will be set to a level of 15 mmHg for as long as needed for the treatment of hydrocephalus, and subsequently weaned at the discretion of the treating physician. Lowering the level of the EVD can be considered by the treating physician if sustained intracranial hypertension occurs
干预措施: CSF Diversion (Procedure)
结局指标
主要结局
Modified Rankin Scale
时间窗: 90-days
The primary outcome is clinical outcome at 90 days. A favorable outcome is defined as a score of 1 or 2 on the modified Rankin Score (mRS) and poor outcome defined as a mRS of 3-6. This assessment will be made by a clinician who was blinded to the patient's CSF diversion treatment arm.
次要结局
- Infarction(90-days)
- Vasospasm(90-days)
- Shunt placement(90-days)
- Ventriculitis(90-days)
- Modified Rankin Scale(Hospital discharge (average 3 weeks))
- MMSE(90-days)
- Length of ICU stay(Average 3 weeks)