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Traumatic Brain InjuryTRACK-TBINCT02119182

Transforming Research and Clinical Knowledge in Traumatic Brain Injury

An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 100 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
In-Person Outcome Assessment, Phone Outcome Assessment and 3T Magnetic Resonance Imaging (MRI)
How many people
2,996 participants
Where
23 sitesUnited States
Study dates
2 Mar 2014to 31 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The Investigators will enroll patients presenting to the Emergency Department with a history of acute TBI within the last 24 hours (acute injury) as per American Congress of Rehabilitation Medicine (ACRM) Criteria, in which the patient has sustained a traumatically induced* physiological disruption of brain function, as manifested by ≥ one of the following: Any period of loss of consciousness Any loss of memory for events immediately before or after the accident Any alteration of mental state at the time of the accident (feeling dazed, disoriented, and/or confused) Focal neurologic deficits that may or may not be permanent *Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head.

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • Emory University

    Atlanta, Georgia, 30303

  • Dell Seton Medical Center

    Austin, Texas, 78701

  • University of Texas at Austin

    Austin, Texas, 78712

  • University of Maryland

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Spaulding Rehabilitation Hospital

    Charlestown, Massachusetts, 02129

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Denver Health and Hospitals Authority

    Denver, Colorado, 80204

  • University of Colorado/Craig Hospital

    Englewood, Colorado, 80113

  • Baylor College of Medicine

    Houston, Texas, 77030

  • TIRR Memorial Hermann

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota/Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • University of Pennsylvania/Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California, San Francisco

    San Francisco, California, 94110

  • University of Washington

    Seattle, Washington, 98104

Other trials in United States

About this study

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.

Read the detailed description

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.

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.

Being tested
In-Person Outcome Assessment, Phone Outcome Assessment, 3T Magnetic Resonance Imaging (MRI), Blood Draw for Plasma, DNA, Serum, RNA
Keywords
Traumatic Brain Injury, Biomarkers, Neuroimaging, Psychological Health, Comparative Effectiveness Research
Medical subject headings
Brain Injuries, Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-Person Outcome AssessmentBehavioural

    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 AssessmentBehavioural

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

  • 3T Magnetic Resonance Imaging (MRI)Procedure or surgery

    3T Research MRI at 2 weeks and 6 months.

  • Blood Draw for Plasma, DNA, Serum, RNAProcedure or surgery

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

Study groups in NCT02119182
Study groupRoleWhat they receive
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).
Receives: Behavioral: In-Person Outcome Assessment; Procedure: 3T Magnetic Resonance Imaging (MRI); Procedure: Blood Draw for Plasma, DNA, Serum, RNA
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).
Receives: Behavioral: In-Person Outcome Assessment; Procedure: 3T Magnetic Resonance Imaging (MRI); Procedure: Blood Draw for Plasma, DNA, Serum, RNA
Brief Assessment• Telephone outcome assessment at 2 weeks, 3 months, 6 months, and 12 months.
Receives: Behavioral: Phone Outcome Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glasgow Outcome Scale - Extended (GOS-E)

    The Glasgow Outcome Scale - Extended (GOS-E) is the current gold standard of outcome for TBI.

    Measured: 6 Months

Secondary outcomes (9)

  1. 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)

    • Sagittal 3D T1 MPRAGE/IR-SPGR
    • Sagittal 3D T2* GRE
    • Axial Diffusion Tensor Imaging (DTI)
    • Axial Resting State Functional MRI (fMRI)
    • Sagittal 3D T2-FLAIR
    • Sagittal 3D T2

    Measured: 2 Weeks

  2. Blood Specimen for Analysis of Biomarkers and Genetics

    • 6.0ml blood for plasma and DNA
    • 6.0ml blood for serum
    • 2.5ml blood for RNA

    Measured: Baseline Visit (In-Hospital)

  3. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)

    Abbreviated Battery

    • GOS-E
    • Confusion Assessment Protocol - Cognitive (CAP-COG)
    • Coma Recovery Scale Revised (CRS-R)

    Comprehensive Assessment Battery

    • GOS-E
    • Expanded Disability Rating Scale (E-DRS-PI)
    • Rey Auditory Verbal Learning Test (RAVLT)
    • Trail Making Test (TMT)
    • Wechsler Adult Intelligence Scale IV (WAIS)
    • Brief Test of Adult Cognition by Telephone (BTACT)
    • Rivermead Post-Concussion Symptoms Questionnaire
    • Pain Intensity and Interference Instruments (PROMIS-PAIN)
    • Insomnia Severity Index (ISI)
    • Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS)
    • Mayo-Portland Adaptability Inventory - Participation (MPAI-PART)
    • Satisfaction with Life Scale (SWLS)
    • 12-Item Short Form Survey (SF-12)
    • Alcohol Use Disorders Identification Test 3-Item (AUDIT-C)
    • 3-Item Drug Use Interview
    • Post-Traumatic Stress Disorder Checklist 5 (PCL-5)
    • Brief Symptom Inventory 18 (BSI18)
    • Participant Health Questionnaire 9 (PHQ-9)

    Measured: 2 Weeks

  4. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)

    Abbreviated Battery

    • GOS-E
    • Confusion Assessment Protocol - Cognitive (CAP-COG)
    • Coma Recovery Scale Revised (CRS-R)

    Comprehensive Assessment Battery

    • GOS-E
    • Expanded Disability Rating Scale (E-DRS-PI)
    • Rey Auditory Verbal Learning Test (RAVLT)
    • Trail Making Test (TMT)
    • Wechsler Adult Intelligence Scale IV (WAIS)
    • Brief Test of Adult Cognition by Telephone (BTACT)
    • Rivermead Post-Concussion Symptoms Questionnaire
    • Pain Intensity and Interference Instruments (PROMIS-PAIN)
    • Insomnia Severity Index (ISI)
    • Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS)
    • Mayo-Portland Adaptability Inventory - Participation (MPAI-PART)
    • Satisfaction with Life Scale (SWLS)
    • 12-Item Short Form Survey (SF-12)
    • Alcohol Use Disorders Identification Test 3-Item (AUDIT-C)
    • 3-Item Drug Use Interview
    • Post-Traumatic Stress Disorder Checklist 5 (PCL-5)
    • Brief Symptom Inventory 18 (BSI18)
    • Participant Health Questionnaire 9 (PHQ-9)

    Measured: 3 Months

  5. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)

    Abbreviated Battery

    • GOS-E
    • Confusion Assessment Protocol - Cognitive (CAP-COG)
    • Coma Recovery Scale Revised (CRS-R)

    Comprehensive Assessment Battery

    • GOS-E
    • Expanded Disability Rating Scale (E-DRS-PI)
    • Rey Auditory Verbal Learning Test (RAVLT)
    • Trail Making Test (TMT)
    • Wechsler Adult Intelligence Scale IV (WAIS)
    • Brief Test of Adult Cognition by Telephone (BTACT)
    • Rivermead Post-Concussion Symptoms Questionnaire
    • Pain Intensity and Interference Instruments (PROMIS-PAIN)
    • Insomnia Severity Index (ISI)
    • Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS)
    • Mayo-Portland Adaptability Inventory - Participation (MPAI-PART)
    • Satisfaction with Life Scale (SWLS)
    • 12-Item Short Form Survey (SF-12)
    • Alcohol Use Disorders Identification Test 3-Item (AUDIT-C)
    • 3-Item Drug Use Interview
    • Post-Traumatic Stress Disorder Checklist 5 (PCL-5)
    • Brief Symptom Inventory 18 (BSI18)
    • Participant Health Questionnaire 9 (PHQ-9)

    Measured: 12 Months

  6. 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI)

    • Sagittal 3D T1 MPRAGE/IR-SPGR
    • Sagittal 3D T2* GRE
    • Axial Diffusion Tensor Imaging (DTI)
    • Axial Resting State Functional MRI (fMRI)
    • Sagittal 3D T2-FLAIR
    • Sagittal 3D T2

    Measured: 6 Months

  7. Blood Specimen for Analysis of Biomarkers and Genetics

    • 6.0ml blood for plasma
    • 6.0ml blood for serum
    • 2.5ml blood for RNA

    Measured: 2 Weeks

  8. Blood Specimen for Analysis of Biomarkers and Genetics

    • 6.0ml blood for plasma
    • 6.0ml blood for serum
    • 2.5ml blood for RNA

    Measured: 6 Months

  9. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure)

    Abbreviated Battery

    • GOS-E
    • Confusion Assessment Protocol - Cognitive (CAP-COG)
    • Coma Recovery Scale Revised (CRS-R)

    Comprehensive Assessment Battery

    • GOS-E
    • Expanded Disability Rating Scale (E-DRS-PI)
    • Rey Auditory Verbal Learning Test (RAVLT)
    • Trail Making Test (TMT)
    • Wechsler Adult Intelligence Scale IV (WAIS)
    • Brief Test of Adult Cognition by Telephone (BTACT)
    • Rivermead Post-Concussion Symptoms Questionnaire
    • Pain Intensity and Interference Instruments (PROMIS-PAIN)
    • Insomnia Severity Index (ISI)
    • Quality of Life After Brain Injury Overall Scale (QOLIBRI-OS)
    • Mayo-Portland Adaptability Inventory - Participation (MPAI-PART)
    • Satisfaction with Life Scale (SWLS)
    • 12-Item Short Form Survey (SF-12)
    • Alcohol Use Disorders Identification Test 3-Item (AUDIT-C)
    • 3-Item Drug Use Interview
    • Post-Traumatic Stress Disorder Checklist 5 (PCL-5)
    • Brief Symptom Inventory 18 (BSI18)
    • Participant Health Questionnaire 9 (PHQ-9)

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study start2 Mar 2014
  3. Primary completion22 Jun 2019
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,996 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02119182
Sponsor's protocol ID
1U01NS086090-01
Other IDs
1U01NS086090-01
Acronym
TRACK-TBI
Status last verified
Sep 2020
First submitted
22 Mar 2014
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Godfrey D, Bambrick M, Hotz G, Jain S, Yuh EL, Rincon S, Sun X, Fortes C, Manley GT, Duhaime AC; TRACK-TBI Investigators. Association Between Plasma Glial Fibrillary Acidic Protein, Ubiquitin Carboxy-Terminal Hydrolase-L1, S100B, and High-Sensitivity C-Reactive Protein Levels, Clinical Findings, and Imaging Abnormalities in Children with Traumatic Brain Injury: A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study. J Neurotrauma. 2026 Apr;43(7-8):544-558. doi: 10.1177/08977151251384319. Epub 2025 Nov 3.

    PubMed 42093199

  • Gotthardt CJ, Barber JK, Eagle SR, van Essen TA, Nelson LD, Fu AY, Satris GG, Vreeburg RJG, Tracey JX, Etemad LL, Wong JC, Elguindy MM, Belton PJ, Madhok DY, Korley FK, Ferguson AR, Torres-Espin A, Duhaime AC, Halabi C, Huang MC, Tarapore PE, DiGiorgio AM, Valadka AB, Robertson CS, Mukherjee P, Yuh EL, Puccio AM, Okonkwo DO, Giacino JT, McCrea MA, Temkin NR, Manley GT, Yue JK; TRACK-TBI Investigators. Longitudinal pain intensity and interference symptomatology in mild traumatic brain injury: a TRACK-TBI study. Pain. 2026 May 1;167(5):e86-e98. doi: 10.1097/j.pain.0000000000003869. Epub 2025 Nov 19.

    PubMed 41734261

  • Yue JK, Fu AY, Elguindy MM, van Essen TA, Eagle SR, Caldwell DJ, Vassar MJ, Belton PJ, Gotthardt CJ, Bhattacharyay S, Chung JE, Satris GG, Vreeburg RJG, Schneider ALC, Lui A, Madhok DY, Halabi C, Ferguson AR, Huang MC, Tarapore PE, DiGiorgio AM, Markowitz AJ, Robertson CS, Mukherjee P, Yuh EL, McCrea MA, Duhaime AC, Hinson HE, Puccio AM, Valadka AB, Okonkwo DO, Sun X, Jain S, Manley GT; TRACK-TBI Investigators. Neuroworsening from a normal Glasgow Coma Scale Motor Score in the emergency department is an early predictor of neurosurgical intervention, hospital outcomes, and longitudinal disability in traumatic brain injury: A TRACK-TBI Study. Injury. 2026 May;57(5):113089. doi: 10.1016/j.injury.2026.113089. Epub 2026 Feb 6.

    PubMed 41672813

  • 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.

    PubMed 39497836

  • 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.

    PubMed 39081460

  • 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.

    PubMed 35963263

  • 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.

    PubMed 35065038

  • 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.

    PubMed 32769835

  • 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.

    PubMed 31451409

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by University of California, San Francisco at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glasgow Outcome Scale - Extended (GOS-E) (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02119182, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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