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Trial record 18 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI)

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ClinicalTrials.gov Identifier: NCT02119182
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : September 26, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Department of Health and Human Services
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Behavioral: In-Person Outcome Assessment Behavioral: Phone Outcome Assessment Procedure: 3T Magnetic Resonance Imaging (MRI) Procedure: Blood Draw for Plasma, DNA, Serum, RNA

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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.

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.


Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transforming Research and Clinical Knowledge in Traumatic Brain Injury
Study Start Date : February 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
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.

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).

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).
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.

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).

Brief Assessment
• Telephone outcome assessment at 2 weeks, 3 months, 6 months, and 12 months.
Behavioral: Phone Outcome Assessment
NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.




Primary Outcome Measures :
  1. Glasgow Outcome Scale - Extended (GOS-E) [ Time Frame: 6 Months ]
    The Glasgow Outcome Scale - Extended (GOS-E) is the current gold standard of outcome for TBI.


Secondary Outcome Measures :
  1. 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) [ Time Frame: 2 Weeks ]
    • 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

  2. Blood Specimen for Analysis of Biomarkers and Genetics [ Time Frame: Baseline Visit (In-Hospital) ]
    • 6.0ml blood for plasma and DNA
    • 6.0ml blood for serum
    • 2.5ml blood for RNA

  3. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 2 Weeks ]

    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)

  4. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 3 Months ]

    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)

  5. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 12 Months ]

    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)

  6. 3T Brain Structural and Functional Magnetic Resonance Imaging (MRI) [ Time Frame: 6 Months ]
    • 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

  7. Blood Specimen for Analysis of Biomarkers and Genetics [ Time Frame: 2 Weeks ]
    • 6.0ml blood for plasma
    • 6.0ml blood for serum
    • 2.5ml blood for RNA

  8. Blood Specimen for Analysis of Biomarkers and Genetics [ Time Frame: 6 Months ]
    • 6.0ml blood for plasma
    • 6.0ml blood for serum
    • 2.5ml blood for RNA

  9. TRACK-TBI Flexible Outcome Assessment Battery Framework (Composite Measure) [ Time Frame: 6 Months ]

    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)


Biospecimen Retention:   Samples With DNA
Plasma, Serum, DNA, and RNA will be collected at the time of injury. Plasma, Serum, and RNA will be collected at Day 3 and Day 5 if patient is in the hospital, and at 2 weeks and 6 months post-injury. Samples will be banked at -80 degrees Celsius.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will enroll adult patients of all ages presenting to the Emergency Department with a history of acute TBI 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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119182


Contacts
Contact: Sabrina R Taylor, PhD, CCRP 415-206-4457 sabrina.taylor@ucsf.edu
Contact: Mary Vassar, RN, MS 415-206-8300 vassarm@neurosurg.ucsf.edu

  Show 23 Study Locations
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Department of Health and Human Services
Investigators
Study Director: Geoffrey T. Manley, MD, PhD University of California, San Francisco
Study Director: Claudia S. Robertson, MD Baylor College of Medicine
Study Director: David O. Okonkwo, MD, PhD University of Pittsburgh
Study Director: Ramon Diaz-Arrastia, MD, PhD University of Pennsylvania
Study Director: Nancy R. Temkin, PhD University of Washington
Study Director: Pratik Mukherjee, MD, PhD University of California, San Francisco
Study Director: Joseph T. Giacino, MD, PhD Harvard Medical School, Spaulding Rehabilitation Hospital
Principal Investigator: Ann-Christine Duhaime, MD Harvard Medical School, Massachusetts General Hospital
Principal Investigator: Dana P. Goldman, PhD University of Southern California
Principal Investigator: Arthur W. Toga, PhD University of Southern California
Principal Investigator: Kevin Smith, MSIS University of Michigan
Principal Investigator: Opeolu M. Adeoye, MD University of Cincinnati
Principal Investigator: Neeraj Badjatia, MD, MS University of Maryland
Principal Investigator: Randall M. Chesnut, MD University of Washington
Principal Investigator: Gillian A. Hotz, PhD University of Miami
Principal Investigator: Christopher J. Madden, MD University of Texas
Principal Investigator: Randall E. Merchant, PhD Virginia Commonwealth University
Principal Investigator: Alex B. Valadka, MD Seton Healthcare Family
Principal Investigator: Andrew I. Maas, MD, PhD Antwerp University Hospital, Edegem, Belgium
Principal Investigator: David K. Menon, MD, PhD University of Cambridge, Cambridge, United Kingdom
Principal Investigator: Isabelle Gagnon, PhD, MS McGill University
Study Director: Murray B Stein, MD, MPH University of California, San Diego
Principal Investigator: Ryan S Kitagawa, MD The University of Texas Health Science Center, Houston
Principal Investigator: David M Schnyer, PhD University of Texas, Austin
Principal Investigator: Vincent Y Wang, MD, PhD, MBA Dell Seton Medical Center
Principal Investigator: David W Wright, MD, FACEP Emory University
Principal Investigator: Michael McCrea, PhD, ABPP Medical College of Wisconsin
Principal Investigator: Gregory Hawryluk, MD, PhD University of Utah
Principal Investigator: Richard B Rodgers, MD, FAANS Indiana University
Principal Investigator: Uzma Samadani, MD, PhD University of Minnesota/Hennepin County Medical Center
Principal Investigator: Mitchell Cohen, MD Denver Health and Hospital Authority
Principal Investigator: Cindy Harrison-Felix, PhD, FACRM University of Colorado, Denver/Craig Hospital
Principal Investigator: Roland Torres, MD University of Miami

Additional Information:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02119182     History of Changes
Other Study ID Numbers: 1U01NS086090-01 ( U.S. NIH Grant/Contract )
1U01NS086090-01 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Traumatic Brain Injury
Biomarkers
Neuroimaging
Psychological Health
Comparative Effectiveness Research

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System