Transforming Research and Clinical Knowledge in Traumatic Brain Injury

Status: Completed
Location: See all (23) locations...
Intervention Type: Procedure, Behavioral
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 100
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
University of California, San Francisco
San Francisco
Colorado
Denver Health and Hospitals Authority
Denver
University of Colorado/Craig Hospital
Englewood
Florida
University of Miami
Miami
Georgia
Emory University
Atlanta
Indiana
Indiana University
Indianapolis
Massachusetts
Massachusetts General Hospital
Boston
Spaulding Rehabilitation Hospital
Charlestown
Maryland
University of Maryland
Baltimore
Minnesota
University of Minnesota/Hennepin County Medical Center
Minneapolis
Ohio
University of Cincinnati
Cincinnati
Pennsylvania
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Texas
Dell Seton Medical Center
Austin
University of Texas at Austin
Austin
University of Texas Southwestern
Dallas
Baylor College of Medicine
Houston
TIRR Memorial Hermann
Houston
University of Texas Health Science Center at Houston
Houston
Utah
University of Utah
Salt Lake City
Virginia
Virginia Commonwealth University
Richmond
Washington
University of Washington
Seattle
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2014-03-02
Completion Date: 2020-08-31
Participants
Target number of participants: 2996
Treatments
Comprehensive Assessment with MRI
* In-Person Outcome Assessment at 2 weeks, 6 months, and 12 months.~* Phone Outcome Assessment at 3 months.~* 3T Magnetic Resonance Imaging (MRI) at 2 weeks and 6 months.~* Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).
Comprehensive Assessment without MRI
* In-Person Outcome Assessment at 2 weeks, 6 months, and 12 months.~* Phone Outcome Assessment at 3 months.~* Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).
Brief Assessment
• Telephone outcome assessment at 2 weeks, 3 months, 6 months, and 12 months.
Authors
Jed A. Hartings, Paulina Sergot, Alex B. Valadka, Gregory Hawryluk, Kim L. Rickert, Randall M. Chesnut, Jonathan Rosand, Stephen A. Figueroa, Uzma Samadani, Arthur M. Pancioli, Norberto Andaluz, Ann-Christine Duhaime, Achala S. Vagal, Roland Torres, Christiana E. Hall, Opeolu Adeoye, Claudia S. Robertson, Ryan S Kitagawa, Richard B Rodgers, Pratik Mukherjee, Jason T. McMullan, Jonathan J. Ratcliff, Ross Zafonte, Ramon Diaz-Arrastia, Esther L. Yuh, Neeraj Badjatia, Geoffrey T. Manley, Christopher J. Madden
Related Therapeutic Areas
Traumatic Brain Injury
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institutes of Health (NIH), Department of Health and Human Services, National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov

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