Biomarkers of Mild and Moderate Traumatic Brain Injury

Brain Injuries, Traumatic Clinical Trial

Official title:

Biomarkers of Mild and Moderate Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295346
• Other study ID #: ATO-04b
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: August 7, 2017
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2017
• Source: Banyan Biomarkers, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Other:
• Head CT scan and blood draw

Locations

Country	Name	City	State
Hungary	University of Pecs	Pecs
Hungary	University of Szeged	Szeged
United States	Dekalb Medical Center	Decatur	Georgia
United States	Wayne State University	Detroit	Michigan
United States	Shands at University Florida Gainesville	Gainesville	Florida
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Banyan Biomarkers, Inc

Countries where clinical trial is conducted

United States,  Hungary, 

References & Publications (1)

Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of pituitary status and determination of the presence of autoantibodies		Day 35
Primary	Assessment of putative TBI markers relative to diagnosis		within 24 hours and at Day 35
Secondary	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