Evaluation of Biomarkers of Traumatic Brain Injury

A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01426919

Acronym

ALERT-TBI

Enrollment

2011

Registered

2011-09-01

Start date

2012-12-31

Completion date

2017-07-31

Last updated

2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury, Head Injury

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.

Interventions

OTHERHead CT scan and blood draw within 12 hours of injury

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Correlation of assay result with absence of acute intracranial lesions	Day 1

Countries

Germany, Hungary, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026