Investigation on the Prognostic Value of Biochemical Markers in the Cerebrospinal Fluid for the Functional Outcome of Spinal Cord Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment
研究概览
简要总结
The project is aimed to develop predictive indices of spinal cord injury severity through the analysis of cerebrospinal fluid of patient collected during acute injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of cervical and thoracic Spinal Cord Injury
- •need to be submitted to spine surgical stabilization with posterior approach
排除标准
- •prior to recruitment, in the acute phase, treatment with steroid therapy
研究组 & 干预措施
lumbar puncture
That's not really an arm label because the only intervention on the patients is the lumbar puncture
干预措施: Lumbar puncture (Other)
结局指标
主要结局
Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment
时间窗: Three years
Correlation of the dosage of more than 20 tentative biomarkers with the biological effect of Cerebrospinal Fluid exposure on human cell lines, in order to directly test those effects. The Cerebrospinal Fluid will be encoded using technical procedures, divided into aliquots, quickly frozen and stored at 80°C. Biomarkers will be measured in the Cerebrospinal Fluid, related to: * inflammatory and vascular reaction, by a cytokine panel including 12 different cytokines/chemochines; * neurodegeneration and excitotoxicity, by a panel of 10 different biomarkers.
次要结局
未报告次要终点