NCT02439736已完成不适用
A PROSPECTIVE CLINICAL EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 7
- 主要终点
- Correlation of assay results with presence of acute intracranial lesions
研究概览
简要总结
The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).
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 (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- •A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
- •The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
- •The CT scan and CT report used to determine eligibility must be available.
- •The blood sample is collected as close to the time of head injury as possible, but no later than 12 hours.
- •The Subject or their legal representative is willing to undergo the Informed Consent process prior to enrollment into this study
排除标准
- •Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
- •Time of injury cannot be determined.
- •Primary diagnosis of ischemic or hemorrhagic stroke.
- •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)).
- •The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
- •The subject has a history of neurosurgery within the last 30 days.
- •Administration of blood transfusion after head injury and prior to the study blood draw.
- •The subject is a female who is pregnant or lactating.
- •The Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation. If this criterion applies, a reason must be provided
结局指标
主要结局
Correlation of assay results with presence of acute intracranial lesions
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (7)
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