Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI) - A Pilot Study
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
- 否
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
干预措施: CSF Drainage (Procedure)
No CSF Drainage
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
Brian Kwon
Professor
University of British Columbia
