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Biomarkers of Mild and Moderate Traumatic Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295346
First Posted: February 14, 2011
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
  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 ]

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

  Eligibility

Information from the National Library of Medicine

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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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Saint 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

Publications:
Responsible Party: Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier: NCT01295346     History of Changes
Other Study ID Numbers: ATO-04b
First Submitted: February 7, 2011
First Posted: February 14, 2011
Last Update Posted: August 8, 2017
Last Verified: August 2017

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