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临床试验/NCT02721615
NCT02721615招募中不适用

Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury

St George's, University of London2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年9月最近更新:
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
Intra spinal pressure

研究概览

简要总结

About a thousand people a year in the United Kingdom survive a spinal cord injury but are left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is more than half a billion pounds. We propose that after spinal cord injury, cord pressure at the injury site rises, damaging the spinal cord further by secondary ischaemia. The value of measuring and reducing cord pressure after spinal cord injury is unknown.

The injured spinal cord is compressed by bone malalignment and cord swelling. Current management involves realigning and fixing the bony fragments using metal screws, rods and plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised hypothermia reduces intra spinal pressure and improves metabolism.

We will develop a novel method to measure cord pressure and metabolism at the injury site after spinal cord injury and determine whether the cord pressure rises, for how long, and with what impact on spinal cord metabolism.

This is a pilot study to find out whether spinal cord pressure and metabolism can be measured after spinal cord injury and whether they are effected by treatment choices. We will examine if spinal cord perfusion pressure correlates with clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of traumatic spinal cord injury American Spinal Injuries Association grade A-C spinal cord injury Presents within 72hrs of injury Capacity to consent for study

排除标准

  • Concurrent major co-morbidity likely to influence outcome Other major concurrent injury likely to influence outcome

结局指标

主要结局

Intra spinal pressure

时间窗: 0-7 days

Intra spinal pressure measured for up to 7 days using sub dural probe

Spinal metabolites

时间窗: 0-7 days

Spinal cord metabolites measured using microdialysis probe

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 (2)

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