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临床试验/NCT03065231
NCT03065231招募中不适用

Lumbar Drainage Compared with Extraventricular Drainage of Cerebral Spinal Fluid in Treatment of Patients with Subarachnoid Hemorrhage - a Prospective Randomized Controlled Trial

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Vasopasm

研究概览

简要总结

Vasospasm is a common complication after rupture of intracranial aneurysms causing devastating neurologic deficits and death. Vasospasm has been directly associated with the amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and lumbar drain (LD) have been compared retrospectively yet remain controversial as to which method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would be a prospective randomized trial in which patients would be assigned to EVD or LD and observed to see if one method of intervention is associated with preventing clinical vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an optimal treatment modality to benefit all future patients with ruptured intracranial aneurysms.

详细描述

This study will be a prospective randomized controlled trial. Participants will be patients admitted at UCSD Hillcrest or Thornton Hospital for subarachnoid hemorrhage. Patients will be recruited by the Endovascular Neurosurgical treatment team. Since there are no existing guidelines existing for procedural drainage of subarachnoid blood from the intracranial cisterns, patients are currently treated with either lumbar drain or extraventricular drain. This study would randomize the process of assigning patients to either LD or EVD as part of their treatment package for subarachnoid hemorrhage.

Both EVD and LD are regularly performed at UCSD. Both procedures are equally likely to take place if patients do not have randomization. There is currently no gold standard that dictates whether EVD should be done over LD and vice versa.

Patients will be consented to partake in the study while they are also consented for their usual care in SAH. Briefly, inclusion criteria are patients with Fisher Grade II, III, IV SAH or any aneurysmal SAH patients with radiographic evidence of hydrocephalus. Briefly, exclusion criteria are patients with obstructive hydrocephalus or mass lesion that would preclude lumbar drain placement. Pregnant patients or minors of age <18 will not be included in this study.

There will be two arms of the study: patients randomly assigned to LD and patients randomly assigned to EVD. Randomization will account for Fisher Grade. The two treatment arms will have CSF diversion for 7 days. For patients treated with lumbar drain, patients will have CSF drainage of 10cc/hour for lumbar drain while patients treated with EVD at 15cm above the tragus.

Both an extraventricular drain and a lumbar drain are defined as significant risk devices however both devices are FDA approved and will be utilized in the exact manner that they are intended. Both devices are already regularly utilized and a part of the standard of care for sub arachnoid hemorrhage management and will not be utilized in any novel way. LD and EVD assignment will be randomized through the protocol of the study.

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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will be blinded to the type of intervention that took place.

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients received at the UCSD Medical Center with grade II, III, IV subarachnoid hemorrhage or patients with aneurysmal SAH with radiographic evidence.

排除标准

  • patients under the age of 18, excluding minors from this study

结局指标

主要结局

Vasopasm

时间窗: 0-14 days

Clinical and Radiographic incidence of vasospasm after ruptured intracranial aneurysm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander A. Khalessi MD MS FAANS

Acting Clinical Chief of Neurosurgery

University of California, San Diego

研究点 (2)

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