Transforming Research and Clinical Knowledge in Traumatic Brain Injury

NCT02119182 | Completed

• 1 other identifier: 1U01NS086090-01
• Study Type: observational
• Target: 2,996
• Locations: 1 country
• Sites: 23

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. 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

Keywords

Traumatic Brain Injury; Biomarkers; Neuroimaging; Psychological Health; Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale - Extended (GOS-E)

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

  6 Months

Secondary Outcomes (9)

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

  2 Weeks

• Blood Specimen for Analysis of Biomarkers and Genetics

  Baseline Visit (In-Hospital)

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

  2 Weeks

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

  3 Months

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

  12 Months

Study Arms (3)

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; 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).

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.

Behavioral: Phone Outcome Assessment

Interventions

In-Person Outcome Assessment BEHAVIORAL

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

Comprehensive Assessment with MRI; Comprehensive Assessment without MRI

Phone Outcome Assessment BEHAVIORAL

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

Brief Assessment

3T Magnetic Resonance Imaging (MRI) PROCEDURE

3T Research MRI at 2 weeks and 6 months.

Comprehensive Assessment with MRI; Comprehensive Assessment without MRI

Blood Draw for Plasma, DNA, Serum, RNA PROCEDURE

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

Comprehensive Assessment with MRI; Comprehensive Assessment without MRI

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Department of Health and Human Services: collaborator

Study Sites (23)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Denver Health and Hospitals Authority

Denver, Colorado, 80204, United States

Location

University of Colorado/Craig Hospital

Englewood, Colorado, 80113, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

University of Minnesota/Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania/Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Dell Seton Medical Center

Austin, Texas, 78701, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (6)

• 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.

  PMID: 39497836 DERIVED

• 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.

  PMID: 39081460 DERIVED

• 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.

  PMID: 35963263 DERIVED

• 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.

  PMID: 35065038 DERIVED

• 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.

  PMID: 32769835 DERIVED

• 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.

  PMID: 31451409 DERIVED

Related Links

• NINDS Common Data Elements

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.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Psychological Well-Being

Interventions

Blood Specimen Collection; DNA; RNA

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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 Medical Center

  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

  STUDY DIRECTOR

• 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, College Park

  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

  PRINCIPAL INVESTIGATOR

• Murray B Stein, MD, MPH

  University of California, San Diego

  STUDY DIRECTOR

• Ryan S Kitagawa, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• David M Schnyer, PhD

  University of Texas at 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2014
• First Posted: April 21, 2014
• Study Start: March 2, 2014
• Primary Completion: June 22, 2019
• Study Completion: August 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)