NCT03060109终止不适用
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 317
- 试验地点
- 4
- 主要终点
- Measurement of biomarkers
研究概览
简要总结
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Subject is at least 18 years of age at screening.
- •The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- •The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
- •The venous blood sample is collected no later than 12 hours from the time of head injury.
- •The Subject is competent and willing to undergo the Informed Consent process
排除标准
- •Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
- •Time of suspected head injury cannot be determined.
- •Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
- •Blood transfusion after head injury, and prior to study blood draw
- •Blood donation within 1 week of study enrollment.
- •The subject is a female who is pregnant or lactating.
- •The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation
结局指标
主要结局
Measurement of biomarkers
时间窗: 12 hours
Measurement of UCH-L1 and GFAP using Philips Minicare
次要结局
未报告次要终点
研究者
研究点 (4)
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