Biomarkers of Mild and Moderate Traumatic Brain Injury

August 7, 2017 updated by: Banyan Biomarkers, Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Pecs, Hungary
        • University of Pecs
      • Szeged, Hungary
        • University of Szeged
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at University Florida Gainesville
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of putative TBI markers relative to diagnosis
Time Frame: within 24 hours and at Day 35
within 24 hours and at Day 35

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within 24 hours and at Day 35

Other Outcome Measures

Outcome Measure
Time Frame
Assessment of pituitary status and determination of the presence of autoantibodies
Time Frame: Day 35
Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banyan Biomarkers, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (ESTIMATE)

February 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATO-04b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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