Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Head Injury
Brief summary
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).
Interventions
OTHERBlood draw within 12 hours of head injury
Sponsors
U.S. Army Medical Research and Development Command
Banyan Biomarkers, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of assay results with presence of acute intracranial lesions | Day 1 |
Countries
Germany, United States
Outcome results
None listed