NCT01426919已完成不适用
A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,011
- 试验地点
- 24
- 主要终点
- Correlation of assay result with absence of acute intracranial lesions
研究概览
简要总结
The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.
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
- •subject is at least 18 years of age at screening
- •suspected traumatically induced head injury as a result of insult to the head from external force
- •GCS 9-15 at time of informed consent
- •workup includes head CT scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury
- •blood sample collected within 3 hours of presenting and within 12 hours of injury
- •subject or legal representative is willing to undergo informed consent
排除标准
- •participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable)
- •time of injury cannot be determined
- •primary diagnosis of ischemic or hemorrhagic stroke
- •venipuncture not feasible
- •a condition precluding entry into the CT scanner
- •subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and history of neurosurgery, stroke or TIA within the last 30 days
- •administration of blood transfusion after head injury and prior to study blood draw
- •subject is otherwise determined by the Investigator to be unsuitable for participation
结局指标
主要结局
Correlation of assay result with absence 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 (24)
Loading locations...
相似试验
已完成
不适用
EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDYTraumatic Brain InjuryNCT02439736Banyan Biomarkers, Inc119
已完成
不适用
Evaluation of Biomarker Kinetics After Mild Brain Injury TraumaTraumatic Brain InjuryNCT02541123Banyan Biomarkers, Inc194
已完成
不适用
Developmental OutcomesHypoxic-Ischemic EncephalopathyNCT02264808University of Florida21
Unknown
不适用
Prognostic Biomarker for CRCColorectal CancerNCT03928652Sixth Affiliated Hospital, Sun Yat-sen University1,050
招募中
不适用
Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)Cirrhosis, LiverNAFLDHBVHCVHCCNCT05781568Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis60