Transforming Research and Clinical Knowledge in Traumatic Brain Injury



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:1 - 100
Updated:11/22/2018
Start Date:February 2014
End Date:August 2019
Contact:Sabrina R Taylor, PhD, CCRP
Email:sabrina.taylor@ucsf.edu
Phone:415-206-4457

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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.
We 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.

Effective treatment of traumatic brain injury (TBI) remains one of the greatest unmet needs
in public health. After 3 decades of failed clinical trials, a new approach is needed. Our
proposal, Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI),
establishes a public-private partnership of experienced TBI investigators, and philanthropic
and industry collaborators, who share a mission to accelerate TBI research. TRACK-TBI will
create a large, high quality database that integrates clinical, imaging, proteomic, genomic,
and outcome biomarkers to establish more precise methods for TBI diagnosis and prognosis,
refine outcome assessment, and compare the effectiveness and costs of TBI care.

We hypothesize that this approach will permit investigators to better characterize and
stratify patients, allow meaningful comparisons of treatments and outcomes, and improve the
next generation of clinical trials. We have built on the TRACK-TBI Pilot study (NCT01565551)
and our team's precompetitive collaboration, forged by participation in the TBI Common Data
Elements project (TBI-CDE) and the International TBI Research Initiative (InTBIR). Having
provided the index dataset for the Federal Interagency TBI Research database (FITBIR), we now
propose the following Specific Aims:

Specific Aim 1. To create a widely accessible, comprehensive TBI Information Commons that
integrates clinical, imaging, proteomic, genomic, and outcome biomarkers from subjects across
the age and injury spectra, and provides analytic tools and resources to support TBI
research. Multi- disciplinary teams across 11 sites will enroll 3000 subjects of all ages
across the injury spectrum of concussion to coma. Utilizing TBI-CDEs, along with uniform
standards for acquiring multi-site MRI data, we will expand the TRACK-TBI Pilot informatics
platform, leveraging existing informatics tools to populate FITBIR, yielding a resource for
current and future TBI research and international collaboration.

Specific Aim 2. To validate imaging, proteomic, and genetic biomarkers that will improve
classification of TBI, permit appropriate selection and stratification of patients for
clinical trials, and contribute to the development of a new taxonomy for TBI. We hypothesize
that validated imaging, proteomic, and genetic biomarkers will permit improved patient
classification, beyond traditional categories of mild, moderate and severe TBI.

Subaim 2.1. To establish prognostic imaging biomarkers for TBI based on patho-anatomic
analysis of CT and MRI, as well as quantitative MR volumetrics, diffusion tensor imaging
(DTI), and resting state functional MRI (R-fMRI).

Subaim 2.2. To identify blood-based biomarkers that will provide additional diagnostic and
prognostic information with which to identify TBI phenotypes that can be targeted by specific
therapies.

Subaim 2.3. To identify common polymorphisms in candidate genes associated with outcome after
TBI, and to elucidate causal molecular mechanisms of injury, response, and repair.

Subaim 2.4. To construct a multidimensional TBI classification system incorporating data from
multiple domains that will define homogeneous classes of patients suitable for clinical trial
inclusion.

Specific Aim 3. To evaluate a flexible outcome assessment battery comprised of a broad range
of TBI common data elements that enables assessment of multiple outcome domains across all
phases of recovery and at all levels of TBI severity. When compared with the current gold
standard, the Glasgow Outcome Scale Extended (GOSE), we hypothesize that a flexible and more
discriminating outcome battery reflecting multiple functional domains will more precisely and
efficiently capture outcomes across the course of recovery, at all levels of TBI severity.

Subaim 3.1. To improve the granularity and breadth of TBI outcomes using a flexible outcome
assessment battery that enables basic neurocognitive assessment in subjects too impaired to
undergo standard neuropsychological testing, and comprehensive assessment of cognition,
functional status, mental health, social participation, and quality of life in those
cognitively intact enough to provide valid results.

Subaim 3.2. To determine the efficiency of a flexible outcome assessment battery, as compared
with the GOSE, in reducing sample sizes needed to detect differences between groups.

Subaim 3.3. To identify specific TBI phenotypes amenable to targeted interventions, by
relating patient classification factors (Subaim 2.4) to different outcome factor scores
(Subaim 3.1).

Specific Aim 4. To determine which tests, treatments, and services are effective and
appropriate for which TBI patients, and use this evidence to recommend practices that offer
the best value. We will use established comparative effectiveness research (CER) and health
economics methods to evaluate the ability of each clinical practice to improve outcomes while
containing costs.

Subaim 4.1. To identify patients currently admitted to an ICU who could be safely and
effectively cared for in a floor bed or discharged home with outpatient management, and to
estimate the health and economic impact of changing the management of these patients.

Subaim 4.2. To determine whether routine follow up improves TBI outcomes and minimizes their
economic burden.

Subaim 4.3. To assess variability in management of patients taking antiplatelet agents at the
time of TBI, and the effect of management on progression of intracranial hemorrhage, need for
craniotomy, and outcome.

We expect that achievement of these Specific Aims will advance our understanding of TBI,
improve clinical trial design, lead to more effective patient-specific treatments, and
improve outcome after TBI.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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.
We found this trial at
23
sites
Dallas, Texas 75390
Principal Investigator: Christopher J. Madden, MD
Phone: 214-648-9362
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: David Wright, MD
Phone: 404-778-1762
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ann-Christine Duhaime, MD
Phone: 617-724-2170
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Boston, MA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Claudia S. Robertson, MD
Phone: 713-873-2789
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Ryan S Kitagawa, MD
Phone: 972-746-5398
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Richard B Rodgers, MD
Phone: 317-396-1298
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Gillian A. Hotz, PhD
Phone: 305-585-6096
University of Miami A private research university with more than 15,000 students from around the...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Gregory Hawryluk, MD, PhD
University of Utah Research is a major component in the life of the U benefiting...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Nancy R. Temkin, PhD
Phone: 206-744-9319
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Austin, Texas 78712
Principal Investigator: David M. Schnyer, PhD
Phone: 512-232-7830
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Austin, Texas 78701
Principal Investigator: Vincent Y Wang, MD, PhD, MBA
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Neeraj Badjatia, MD
Phone: 410-328-6844
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Charlestown, Massachusetts 02129
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Opeolu Adeoye, MD
Phone: 513-558-6142
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Denver, Colorado 80204
Principal Investigator: Mitchell Cohen, MD
Phone: 303-602-1863
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Englewood, Colorado 80113
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Houston, Texas 77030
Principal Investigator: Mark Sherer, PhD
Phone: 713-797-7106
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Michael McCrea, PhD, ABPP
Phone: 414-955-7304
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55415
Principal Investigator: Uzma Samadani, MD, PhD
Phone: 612-873-9259
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Philadelphia, Pennsylvania 19104
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD
Phone: 267-285-6150
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: David O. Okonkwo, MD, PhD
Phone: 412-648-9664
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Randall E. Merchant, PhD
Phone: 804-338-0481
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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San Francisco, California 94143
Principal Investigator: Geoffrey T. Manley, MD, PhD
Phone: 415-206-4457
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