Biomarkers of Mild and Moderate Traumatic Brain Injury

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01295346

Enrollment

290

Registered

2011-02-14

Start date

2011-01-31

Completion date

2012-03-31

Last updated

2017-08-08

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

Conditions

Brain Injuries, Traumatic

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.

Interventions

OTHERHead CT scan and blood draw

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Other

Measure	Time frame
Assessment of pituitary status and determination of the presence of autoantibodies	Day 35

Countries

Hungary, United States

Outcome results

None listed

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