Biomarkers of Mild and Moderate Traumatic Brain Injury

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Other: Head CT scan and blood draw

• Registration Number: NCT01295346
• Lead Sponsor: Banyan Biomarkers, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. At least 18 years of age and no more than 80 years of age.
2. Closed injury to the head within 4 hours from symptom onset.
3. Glasgow Coma Scale (GCS) Score of 9-15.
4. Head Computerized Tomography (CT) performed as part of routine care.
5. Subject is willing to undergo the Informed Consent process prior to enrollment.
6. Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traumatic Brain Injury	Head CT scan and blood draw	Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury

Primary Outcome Measures

Name	Time	Method
Assessment of putative TBI markers relative to diagnosis	within 24 hours and at Day 35

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Dekalb Medical Center; 🇺🇸 Decatur, Georgia, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Pecs; 🇭🇺 Pecs, Hungary

University of Szeged; 🇭🇺 Szeged, Hungary

Shands at University Florida Gainesville; 🇺🇸 Gainesville, Florida, United States

Gwinnett Medical Center; 🇺🇸 Lawrenceville, Georgia, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States