Transforming Research and Clinical Knowledge in Traumatic Brain Injury

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.

Conditions

• Traumatic Brain Injury

Interventions

BEHAVIORAL

In-Person Outcome Assessment

NIH Flexible Outcome Assessment Battery Framework Measures In-Person at 2 Weeks, 6 Months, and 12 Months, and by Phone at 3 Months.

BEHAVIORAL

Phone Outcome Assessment

NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.

PROCEDURE

3T Magnetic Resonance Imaging (MRI)

3T Research MRI at 2 weeks and 6 months.

PROCEDURE

Blood Draw for Plasma, DNA, Serum, RNA

Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Department of Health and Human Services

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Geoffrey T. Manley, MD, PhD · University of California, San Francisco

• Claudia S. Robertson, MD · Baylor College of Medicine

• David O. Okonkwo, MD, PhD · University of Pittsburgh Medical Center

• Ramon Diaz-Arrastia, MD, PhD · University of Pennsylvania

• Nancy R. Temkin, PhD · University of Washington

• Pratik Mukherjee, MD, PhD · University of California, San Francisco

• Joseph T. Giacino, MD, PhD · Harvard Medical School, Spaulding Rehabilitation Hospital

• Ann-Christine Duhaime, MD · Harvard Medical School, Massachusetts General Hospital

• Dana P. Goldman, PhD · University of Southern California

• Arthur W. Toga, PhD · University of Southern California

• Kevin Smith, MSIS · University of Michigan

• Opeolu M. Adeoye, MD · University of Cincinnati

• Neeraj Badjatia, MD, MS · University of Maryland, College Park

• Randall M. Chesnut, MD · University of Washington

• Gillian A. Hotz, PhD · University of Miami

• Christopher J. Madden, MD · University of Texas

• Randall E. Merchant, PhD · Virginia Commonwealth University

• Alex B. Valadka, MD · Seton Healthcare Family

• Andrew I. Maas, MD, PhD · Antwerp University Hospital, Edegem, Belgium

• David K. Menon, MD, PhD · University of Cambridge, Cambridge, United Kingdom

• Isabelle Gagnon, PhD, MS · McGill University

• Murray B Stein, MD, MPH · University of California, San Diego

• Ryan S Kitagawa, MD · The University of Texas Health Science Center, Houston

• David M Schnyer, PhD · University of Texas - Austin

• Vincent Y Wang, MD, PhD, MBA · Dell Seton Medical Center

• David W Wright, MD, FACEP · Emory University

• Michael McCrea, PhD, ABPP · Medical College of Wisconsin

• Gregory Hawryluk, MD, PhD · University of Utah

• Richard B Rodgers, MD, FAANS · Indiana University

• Uzma Samadani, MD, PhD · University of Minnesota/Hennepin County Medical Center

• Mitchell Cohen, MD · Denver Health and Hospital Authority

• Cindy Harrison-Felix, PhD, FACRM · University of Colorado, Denver/Craig Hospital

• Roland Torres, MD · University of Miami

Eligibility

Min Age

1 Year

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-02

Primary Completion

2019-06-22

Completion

2020-08-31

Countries

• United States

Study Locations