NCT01295346已完成不适用
Biomarkers of Mild and Moderate Traumatic Brain Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 7
- 主要终点
- Assessment of putative TBI markers relative to diagnosis
研究概览
简要总结
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and no more than 80 years of age.
- •Closed injury to the head within 4 hours from symptom onset.
- •Glasgow Coma Scale (GCS) Score of 9-
- •Head Computerized Tomography (CT) performed as part of routine care.
- •Subject is willing to undergo the Informed Consent process prior to enrollment.
- •Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.
排除标准
- •Participating in another clinical study that may affect the results of either study.
- •Time of injury cannot be determined.
- •Head CT not done as part of clinical emergency care.
- •Primary diagnosis of ischemic or hemorrhagic infarct.
- •Not available for 35 day follow-up visit.
- •Venipuncture not feasible.
- •Blood donation within 1 week of screening.
- •The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
结局指标
主要结局
Assessment of putative TBI markers relative to diagnosis
时间窗: within 24 hours and at Day 35
次要结局
- Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT)(within 24 hours and at Day 35)
研究者
研究点 (7)
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