跳至主要内容
临床试验/NCT01169454
NCT01169454终止不适用

Ventriculostomy in SAH: ICP Open or Not?

Duke University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
1
主要终点
Cerebral artery vasospasm

研究概览

简要总结

The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have ICP monitoring. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

详细描述

Patients diagnosed with subarachnoid hemorrhage (SAH) who require intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage will be eligible for this study.

Subjects will be randomized to receive one of two currently accepted methods of ICP management. The first is ICP monitoring with intermittent CSF drainage and the second is through continuous CSF drainage at set pressure thresholds.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Admitted to Duke University NCCU
  • Adult (18 years of age or older)
  • Primary diagnosis is Subarachnoid Hemorrhage
  • Intraventricular catheter in situ

排除标准

  • Glasgow Coma Score = 3
  • Hunt and Hess Score = 5
  • Prisoners
  • Ventriculostomy > 72 hours

结局指标

主要结局

Cerebral artery vasospasm

时间窗: 14 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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