Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI)

Banyan International

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: Head CT scan and blood draw within 12 hours of injury

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01426919

ATO-06

Details and patient eligibility

About

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.

Enrollment: 2,011 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

2,011 participants in 1 patient group

Suspected traumatic brain injury with head CT

Treatment:

Other: Head CT scan and blood draw within 12 hours of injury