This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Biomarkers of Mild and Moderate Traumatic Brain Injury

This study has been completed.
Information provided by (Responsible Party):
Banyan Biomarkers, Inc Identifier:
First received: February 7, 2011
Last updated: March 11, 2013
Last verified: March 2013
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.

Condition Intervention
Brain Injuries, Traumatic Other: Head CT scan and blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Mild and Moderate Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by Banyan Biomarkers, Inc:

Primary Outcome Measures:
  • Assessment of putative TBI markers relative to diagnosis [ Time Frame: within 24 hours and at Day 35 ]

Secondary Outcome Measures:
  • Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT) [ Time Frame: within 24 hours and at Day 35 ]

Other Outcome Measures:
  • Assessment of pituitary status and determination of the presence of autoantibodies [ Time Frame: Day 35 ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum, plasma

Enrollment: 290
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Traumatic Brain Injury
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
Other: Head CT scan and blood draw


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15) within 4 hours of injury.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01295346

United States, Florida
Shands at University Florida Gainesville
Gainesville, Florida, United States, 32610
United States, Georgia
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
University of Pecs
Pecs, Hungary
University of Szeged
Szeged, Hungary
Sponsors and Collaborators
Banyan Biomarkers, Inc
Study Chair: Jackson Streeter, MD Banyan Biomarkers
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Banyan Biomarkers, Inc Identifier: NCT01295346     History of Changes
Other Study ID Numbers: ATO-04b
Study First Received: February 7, 2011
Last Updated: March 11, 2013

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System processed this record on June 23, 2017