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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01295346
Other study ID # ATO-04b
Secondary ID
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
Health authority
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.

Study Design


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
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