Transforming Research and Clinical Knowledge in Traumatic Brain Injury

Completed

Conditions studied: Traumatic Brain Injury

In brief

The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial design. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-TBI site with a brain injury that meets ACRM criteria and receives a clinically indicated head CT.

Key facts

Study ID

NCT02119182

Run by

University of California, San Francisco

People needed

2996

Starts

2014-03-02

Expected to finish

2020-08-31

Last updated by the study team

2020-09-16

Who can join

Age: 1 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-100 (some sites also enrolling pediatric patients)
• Documented/verified TBI by ACRM Criteria
• Injury occurred within 24 hours of ED arrival
• Acute brain CT as part of clinical care
• Visual acuity and hearing adequate for outcomes testing
• Fluency in English (some sites also enrolling Spanish speakers)

You may not qualify if…

• Significant polytrauma that would interfere with follow-up and outcome assessment
• Prisoners or patients in custody
• Pregnancy in female subjects
• Patients on psychiatric hold (e.g. 5150, 5250)
• Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with the validity of outcome assessment due to TBI
• Major debilitating neurological disease (e.g. stroke, CVA, dementia, tumor) impairing baseline awareness, cognition, or validity of outcome assessment due to TBI
• Significant history of pre-existing conditions that would interfere with likelihood of follow-up and validity of outcome assessment due to TBI (e.g. major substance abuse, alcoholism, end-stage cancers, learning disabilities, developmental disorders)
• Contraindications for MR (for CA+MRI cohort)
• Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)
• Current participant in an interventional trial (e.g. drug, device, behavioral)
• Non-English speakers as most outcome measures are normed in the English language.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Denver Health and Hospitals Authority — Denver, Colorado, United States
• University of Colorado/Craig Hospital — Englewood, Colorado, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States
• University of Minnesota/Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Pennsylvania/Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Dell Seton Medical Center — Austin, Texas, United States
• University of Texas at Austin — Austin, Texas, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• TIRR Memorial Hermann — Houston, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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