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临床试验/NCT00787020
NCT00787020已完成不适用

Ventriculostomies in SAH: ICP Open or Not?

Duke University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
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 explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. 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

There are no interventions specific to this observational study. The nurses and physicians who care for subjects in the study are already competent in the care and management of patients with subarachnoid hemorrhage (SAH) and intracranial pressure (ICP) monitoring as a requirement of their current employment at Duke University. Patients with confirmed diagnosis of subarachnoid hemorrhage requiring ICP and CSF management will be admitted to the 16 bed Neurocritical Care Unit (NCCU) at Duke Hospital. After admission procedures and a baseline neurologic assessment are complete, the charge nurse or NCCU fellow will notify an investigator of subjects meeting inclusion criteria. The investigator or research coordinator for this project will complete a review preparatory to research (RPR) to ensure no exclusion criteria are present and once subject appropriateness has been confirmed patients and their families will be introduced to the investigator for the purpose of obtaining informed consent. The subject's legally authorized representative (LAR) will be informed of the study's purpose, risks and benefits, and the rights of research subjects.

Data will be collected that reflects the duration of the patient's hospitalization at Duke University through chart abstraction. The study period will be defined as admission to discharge. The attending physician has, and will continue to, determine the appropriateness of the duration of ICP monitoring, NCCU discharge criteria and hospital discharge criteria. Chart abstraction will be completed daily to obtain the ICP values and CSF volumes during that period of time for which the patient has a ventriculostomy.

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

  • Clinical diagnosis of subarachnoid hemorrhage
  • Age 18 years or older
  • Ventriculostomy in situ

排除标准

  • Prisoners
  • Glasgow coma score = 3

结局指标

主要结局

Cerebral Artery Vasospasm

时间窗: 14 days

Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.

次要结局

  • External Ventricular Drain (EVD) Complications(14 Days)
  • Cerebrospinal Fluid (CSF) Output Per Day(14 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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