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临床试验/NCT00135278
NCT00135278已完成不适用

Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI) - A Pilot Study

University of British Columbia2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2008年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
To evaluate the safety and feasibility of CSF drainage as a potential treatment for patients with acute SCI

研究概览

简要总结

The overall purpose of this pilot study is to evaluate CSF drainage as a potential neuroprotective strategy after acute spinal cord injury (SCI).

详细描述

This pilot study will evaluate the safety and feasibility of a clinical trial protocol for cerebrospinal fluid (CSF) drainage as a potential treatment for patients with acute spinal cord injury. Specifically, the investigators will evaluate:

  • patient eligibility and recruitment for such a study and how soon CSF drainage can be instituted in such patients;
  • adverse events and safety of CSF drain insertion and drainage in the setting of acute spinal cord injury;
  • neurologic recovery after injury; and
  • cytokine expression within the CSF and blood after injury.

Following informed consent, patients with spinal cord injuries who agree to participate in the study will have a lumbar CSF drain placed and be randomized to either:

  • CSF drainage to maintain a constant intrathecal pressure; or
  • no CSF drainage.

Both groups will have CSF and blood sampled at pre-defined intervals in order to evaluate CSF cytokine expression after acute spinal cord injury. For comparison against the injured condition, CSF and blood from a normal group of uninjured individuals will be obtained. These individuals will be patients undergoing hip or knee surgery under a spinal anesthetic, where a small sample of CSF can be taken when their intrathecal space is accessed for the anesthesia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Injured subjects:
  • Complete or incomplete acute SCI between C0 and T11
  • Admitted within 48 hours of injury
  • Undergoing spinal decompressive surgery
  • Undergoing lumbar puncture for spinal anesthetic or myelography
  • Neurologically intact

排除标准

  • Pre-existing neurodegenerative disorder
  • Associated head or spine injury

研究组 & 干预措施

CSF Drainage

Other

干预措施: CSF Drainage (Procedure)

No CSF Drainage

Other

干预措施: No CSF Drainage (Procedure)

结局指标

主要结局

To evaluate the safety and feasibility of CSF drainage as a potential treatment for patients with acute SCI

次要结局

  • To determine if CSF drainage will improve neurologic function after acute SCI
  • To evaluate the temporal pattern of expression of inflammatory cytokines within the CSF

研究者

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

Brian Kwon

Professor

University of British Columbia

研究点 (2)

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