Biomarkers of Mild and Moderate Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier:
NCT01295346
First received: February 7, 2011
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assessment of pituitary status and determination of the presence of autoantibodies [ Time Frame: Day 35 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT01295346

Locations
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
Hungary
University of Pecs
Pecs, Hungary
University of Szeged
Szeged, Hungary
Sponsors and Collaborators
Banyan Biomarkers, Inc
Investigators
Study Chair: Jackson Streeter, MD Banyan Biomarkers
  More Information

No publications provided

Responsible Party: Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier: NCT01295346     History of Changes
Other Study ID Numbers: ATO-04b
Study First Received: February 7, 2011
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board
Hungary: Institutional Ethics Committee

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014