NCT02262286已完成不适用
Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Measurement of specific biomarker(s) for brain injury
研究概览
简要总结
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.
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
- 是
入选标准
- •Informed Consent Form Signed
- •18 years of age or older
- •For women of child-bearing age: Not known to be pregnant AND
- •Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
- •Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
- •Bone fracture or poly-traumas, both with no head trauma
排除标准
- •Known pre-existing neurological condition that causes observed symptoms
- •Recent history of head injury or seizures (within 1 year of current ED presentation)
结局指标
主要结局
Measurement of specific biomarker(s) for brain injury
时间窗: 48 hours
Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.
次要结局
未报告次要终点
研究者
研究点 (1)
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