Status:
COMPLETED
Evaluation of Biomarkers of Traumatic Brain Injury
Lead Sponsor:
Banyan Biomarkers, Inc
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
2011 Patients enrolled
Trial Details
Trial ID
NCT01426919
Start Date
December 1 2012
End Date
July 1 2017
Last Update
December 16 2020
Active Locations (24)
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1
University of California San Diego
San Diego, California, United States, 92103
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
3
University of Florida
Gainesville, Florida, United States, 32610
4
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308