Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Accumulated Hb and bilirubin in CSF drainage
研究概览
简要总结
Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.
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
- •Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
- •In need for CSF drainage based on clinical judgment
排除标准
- •intraventricular clots
- •intraparenchymal clots causing midline shift
- •pregnancy
结局指标
主要结局
Accumulated Hb and bilirubin in CSF drainage
时间窗: From drain placement to removal, in average 10 days.
次要结局
- clinical signs of vasospasms(The participants will be followedd for the duration of hospital stay, in average 3 weeks)
- placement of a ventriculoperitoneal shunt(participants will be followed for the duration of hospital stay, in average 3 weeks)
- Lindegaard ratio (TCD) > 3(the participants will be followed for the duration of hospital stay, in average 3 weeks)
研究者
Peter Birkeland
Staff surgeon
Odense University Hospital