Transforming Research and Clinical Knowledge in Traumatic Brain Injury
NCT ID: NCT02119182
Last Updated: 2020-09-16
Study Results
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Basic Information
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COMPLETED
2996 participants
OBSERVATIONAL
2014-03-02
2020-08-31
Brief Summary
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Detailed Description
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The Investigators 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. The Investigators 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), the Investigators 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, the Investigators 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. The Investigators 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), the Investigators 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. The Investigators 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.
The Investigators 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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.
3T Magnetic Resonance Imaging (MRI)
3T Research MRI at 2 weeks and 6 months.
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).
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).
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.
3T Magnetic Resonance Imaging (MRI)
3T Research MRI at 2 weeks and 6 months.
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).
Brief Assessment
• Telephone outcome assessment at 2 weeks, 3 months, 6 months, and 12 months.
Phone Outcome Assessment
NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.
Interventions
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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.
Phone Outcome Assessment
NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.
3T Magnetic Resonance Imaging (MRI)
3T Research MRI at 2 weeks and 6 months.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
100 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Department of Health and Human Services
FED
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Geoffrey T. Manley, MD, PhD
Role: STUDY_DIRECTOR
University of California, San Francisco
Claudia S. Robertson, MD
Role: STUDY_DIRECTOR
Baylor College of Medicine
David O. Okonkwo, MD, PhD
Role: STUDY_DIRECTOR
University of Pittsburgh Medical Center
Ramon Diaz-Arrastia, MD, PhD
Role: STUDY_DIRECTOR
University of Pennsylvania
Nancy R. Temkin, PhD
Role: STUDY_DIRECTOR
University of Washington
Pratik Mukherjee, MD, PhD
Role: STUDY_DIRECTOR
University of California, San Francisco
Joseph T. Giacino, MD, PhD
Role: STUDY_DIRECTOR
Harvard Medical School, Spaulding Rehabilitation Hospital
Ann-Christine Duhaime, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School, Massachusetts General Hospital
Dana P. Goldman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Arthur W. Toga, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Kevin Smith, MSIS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Opeolu M. Adeoye, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Neeraj Badjatia, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, College Park
Randall M. Chesnut, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Gillian A. Hotz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Christopher J. Madden, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Randall E. Merchant, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Alex B. Valadka, MD
Role: PRINCIPAL_INVESTIGATOR
Seton Healthcare Family
Andrew I. Maas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Antwerp University Hospital, Edegem, Belgium
David K. Menon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge, Cambridge, United Kingdom
Isabelle Gagnon, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
McGill University
Murray B Stein, MD, MPH
Role: STUDY_DIRECTOR
University of California, San Diego
Ryan S Kitagawa, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
David M Schnyer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas - Austin
Vincent Y Wang, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Dell Seton Medical Center
David W Wright, MD, FACEP
Role: PRINCIPAL_INVESTIGATOR
Emory University
Michael McCrea, PhD, ABPP
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Gregory Hawryluk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Richard B Rodgers, MD, FAANS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Uzma Samadani, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota/Hennepin County Medical Center
Mitchell Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Denver Health and Hospital Authority
Cindy Harrison-Felix, PhD, FACRM
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver/Craig Hospital
Roland Torres, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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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
Countries
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References
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Yue JK, Kanter JH, Barber JK, Huang MC, van Essen TA, Elguindy MM, Foreman B, Korley FK, Belton PJ, Pisica D, Lee YM, Kitagawa RS, Vassar MJ, Sun X, Satris GG, Wong JC, Ferguson AR, Huie JR, Wang KKW, Deng H, Wang VY, Bodien YG, Taylor SR, Madhok DY, McCrea MA, Ngwenya LB, DiGiorgio AM, Tarapore PE, Stein MB, Puccio AM, Giacino JT, Diaz-Arrastia R, Lingsma HF, Mukherjee P, Yuh EL, Robertson CS, Menon DK, Maas AIR, Markowitz AJ, Jain S, Okonkwo DO, Temkin NR, Manley GT; TRACK-TBI Investigators. Clinical profile of patients with acute traumatic brain injury undergoing cranial surgery in the United States: report from the 18-centre TRACK-TBI cohort study. Lancet Reg Health Am. 2024 Oct 17;39:100915. doi: 10.1016/j.lana.2024.100915. eCollection 2024 Nov.
Yue JK, Etemad LL, Elguindy MM, van Essen TA, Belton PJ, Nelson LD, McCrea MA, Vreeburg RJG, Gotthardt CJ, Tracey JX, Coskun BC, Krishnan N, Halabi C, Eagle SR, Korley FK, Robertson CS, Duhaime AC, Satris GG, Tarapore PE, Huang MC, Madhok DY, Giacino JT, Mukherjee P, Yuh EL, Valadka AB, Puccio AM, Okonkwo DO, Sun X, Jain S, Manley GT, DiGiorgio AM; TRACK-TBI Investigators; Badjatia N, Barber J, Bodien YG, Fabian B, Ferguson AR, Foreman B, Gardner RC, Gopinath S, Grandhi R, Russell Huie J, Dirk Keene C, Lingsma HF, MacDonald CL, Markowitz AJ, Merchant R, Ngwenya LB, Rodgers RB, Schneider ALC, Schnyer DM, Taylor SR, Temkin NR, Torres-Espin A, Vassar MJ, Wang KKW, Wong JC, Zafonte RD. Prior traumatic brain injury is a risk factor for in-hospital mortality in moderate to severe traumatic brain injury: a TRACK-TBI cohort study. Trauma Surg Acute Care Open. 2024 Jul 24;9(1):e001501. doi: 10.1136/tsaco-2024-001501. eCollection 2024.
Korley FK, Jain S, Sun X, Puccio AM, Yue JK, Gardner RC, Wang KKW, Okonkwo DO, Yuh EL, Mukherjee P, Nelson LD, Taylor SR, Markowitz AJ, Diaz-Arrastia R, Manley GT; TRACK-TBI Study Investigators. Prognostic value of day-of-injury plasma GFAP and UCH-L1 concentrations for predicting functional recovery after traumatic brain injury in patients from the US TRACK-TBI cohort: an observational cohort study. Lancet Neurol. 2022 Sep;21(9):803-813. doi: 10.1016/S1474-4422(22)00256-3.
Galimberti S, Graziano F, Maas AIR, Isernia G, Lecky F, Jain S, Sun X, Gardner RC, Taylor SR, Markowitz AJ, Manley GT, Valsecchi MG, Bellelli G, Citerio G; CENTER-TBI and TRACK-TBI participants and investigators. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation. Lancet Neurol. 2022 Feb;21(2):153-162. doi: 10.1016/S1474-4422(21)00374-4.
Campbell-Sills L, Jain S, Sun X, Fisher LB, Agtarap SD, Dikmen S, Nelson LD, Temkin N, McCrea M, Yuh E, Giacino JT, Manley GT; TRACK-TBI Investigators. Risk Factors for Suicidal Ideation Following Mild Traumatic Brain Injury: A TRACK-TBI Study. J Head Trauma Rehabil. 2021 Jan-Feb 01;36(1):E30-E39. doi: 10.1097/HTR.0000000000000602.
Yue JK, Yuh EL, Korley FK, Winkler EA, Sun X, Puffer RC, Deng H, Choy W, Chandra A, Taylor SR, Ferguson AR, Huie JR, Rabinowitz M, Puccio AM, Mukherjee P, Vassar MJ, Wang KKW, Diaz-Arrastia R, Okonkwo DO, Jain S, Manley GT; TRACK-TBI Investigators. Association between plasma GFAP concentrations and MRI abnormalities in patients with CT-negative traumatic brain injury in the TRACK-TBI cohort: a prospective multicentre study. Lancet Neurol. 2019 Oct;18(10):953-961. doi: 10.1016/S1474-4422(19)30282-0. Epub 2019 Aug 23.
Related Links
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NINDS Common Data Elements
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