Biomarkers of Mild and Moderate Traumatic Brain Injury

Banyan Biomarkers, Inc7 sites in 2 countries290 target enrollmentJanuary 2011

ConditionsBrain Injuries, Traumatic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Injuries, Traumatic
Sponsor: Banyan Biomarkers, Inc
Enrollment: 290
Locations: 7
Primary Endpoint: Assessment of putative TBI markers relative to diagnosis
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

March 2012

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Banyan Biomarkers, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age and no more than 80 years of age.
•Closed injury to the head within 4 hours from symptom onset.
•Glasgow Coma Scale (GCS) Score of 9-
•Head Computerized Tomography (CT) performed as part of routine care.
•Subject is willing to undergo the Informed Consent process prior to enrollment.
•Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.

Exclusion Criteria

•Participating in another clinical study that may affect the results of either study.
•Time of injury cannot be determined.
•Head CT not done as part of clinical emergency care.
•Primary diagnosis of ischemic or hemorrhagic infarct.
•Not available for 35 day follow-up visit.
•Venipuncture not feasible.
•Blood donation within 1 week of screening.
•The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Outcomes

Primary Outcomes

Assessment of putative TBI markers relative to diagnosis

Time Frame: within 24 hours and at Day 35

Secondary Outcomes

Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT)(within 24 hours and at Day 35)