Evaluation of Biomarkers of Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT01426919
- Lead Sponsor
- Banyan Biomarkers, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2011
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of assay result with absence of acute intracranial lesions Day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
University of California San Diego
🇺🇸San Diego, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Wayne State University - Detroit Receiving Hospital
🇺🇸Detroit, Michigan, United States
Wayne State University - Sinai Grace Hospital
🇺🇸Detroit, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Scroll for more (14 remaining)University of California San Diego🇺🇸San Diego, California, United States