Transforming Research and Clinical Knowledge in TBI Pilot

NCT01565551 | Completed Results

• 1 other identifier: RC2NS069409
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 4

Brief Summary

The global aim of this proposal is to test and refine Common Data Elements (CDEs), neuroimaging standards, and best practices for genetics and proteomics in Traumatic Brain Injury (TBI) studies. Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 TBI Centers (San Francisco General Hospital (SFGH), University of Pittsburgh Medical Center (UPMC), University Medical Center Brackenridge (UMCB)) and a TBI Rehabilitation Center (Mount Sinai Rehabilitation Center (MSMC)). The investigators will create and expand existing data repositories for patient demographics, neuroimaging, plasma biomarkers, genetics, and multivariate outcomes thereby providing researchers and clinicians with the infrastructure to establish multidisciplinary, multicenter research networks and improve clinical research in the TBI field.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Common Data Elements; Prognostic Models; Neuroimaging; Biomarkers; Genetic Variants; Concussion; Psychological Health

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale Extended (GOSE)

  The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.

  6 Months Post-Injury

Study Arms (2)

Early-Presenting TBI: Acute Sites

This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).

Other: N/A (Observational Study)

Late-Presenting TBI: Rehabilitation Center

This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).

Other: N/A (Observational Study)

Interventions

N/A (Observational Study) OTHER

No Interventions: Observational Study

Early-Presenting TBI: Acute Sites; Late-Presenting TBI: Rehabilitation Center

Eligibility Criteria

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

Study Population

This is a population-based TBI study. All patients presenting to the acute sites with traumatic brain injury and receive a head CT scan as part of standard care within 24 hours of injury date and time are initially eligible. As most six-month Common Date Elements (CDE) outcome measures are normed and validated only in English, study participants must be English-speaking. There are no other restrictions to eligibility.

You may qualify if:

• Presentation to Emergency Department \< 24 hours post-injury
• Head CT scan for Traumatic Brain Injury (TBI) as part of regular care.
• English Speaking

You may not qualify if:

• Presentation to Emergency Department \> 24 hours post-injury
• Custody or Incarceration
• Psychiatric Hold
• MRI: Pregnant or may be pregnant; younger than 8 years old; those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, intrauterine devices (IUDs), or metal objects in their body, especially in the eye. Persons with a history of claustrophobia are excluded from this procedure.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (4)

San Francisco General Hospital (SFGH)

San Francisco, California, 94110, United States

Location

Mount Sinai Rehabilitation Center

New York, New York, 10029, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

University Medical Center, Brackenridge

Austin, Texas, 78701, United States

Location

Related Publications (31)

• Finkelstein E, Corso P, Miller T. The Incidence and Economic Burden of Injuries in the United States. New York, NY: Oxford University Press; 2006.

  BACKGROUND

• Foulkes AM, Eisenberg MH, Jane AJ. The Traumatic Coma Data Bank; design, methods and baseline characteristics. J. Neuroch. 75, S1-S15, 1991

  BACKGROUND

• Jagoda AS, Bazarian JJ, Bruns JJ Jr, Cantrill SV, Gean AD, Howard PK, Ghajar J, Riggio S, Wright DW, Wears RL, Bakshy A, Burgess P, Wald MM, Whitson RR. Clinical policy: neuroimaging and decisionmaking in adult mild traumatic brain injury in the acute setting. J Emerg Nurs. 2009 Apr;35(2):e5-40. doi: 10.1016/j.jen.2008.12.010.

  PMID: 19285163 BACKGROUND

• Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.

  PMID: 18635021 BACKGROUND

• Marmarou A, Lu J, Butcher I, McHugh GS, Mushkudiani NA, Murray GD, Steyerberg EW, Maas AI. IMPACT database of traumatic brain injury: design and description. J Neurotrauma. 2007 Feb;24(2):239-50. doi: 10.1089/neu.2006.0036.

  PMID: 17375988 BACKGROUND

• Marshall LF, Marshall SB, Klauber MR, Van Berkum Clark M, Eisenberg H, Jane JA, Luerssen TG, Marmarou A, Foulkes MA. The diagnosis of head injury requires a classification based on computed axial tomography. J Neurotrauma. 1992 Mar;9 Suppl 1:S287-92.

  PMID: 1588618 BACKGROUND

• MRC CRASH Trial Collaborators; Perel P, Arango M, Clayton T, Edwards P, Komolafe E, Poccock S, Roberts I, Shakur H, Steyerberg E, Yutthakasemsunt S. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. 2008 Feb 23;336(7641):425-9. doi: 10.1136/bmj.39461.643438.25. Epub 2008 Feb 12.

  PMID: 18270239 BACKGROUND

• Murray GD, Teasdale GM, Braakman R, Cohadon F, Dearden M, Iannotti F, Karimi A, Lapierre F, Maas A, Ohman J, Persson L, Servadei F, Stocchetti N, Trojanowski T, Unterberg A. The European Brain Injury Consortium survey of head injuries. Acta Neurochir (Wien). 1999;141(3):223-36. doi: 10.1007/s007010050292.

  PMID: 10214478 BACKGROUND

• Ng J, Wahl M, Tong L, Lee H, Veeraraghavan S, Xu D, Zhao S, Kornak J, Meeker M, Ghajar J, Manley GT, Mukherjee P. 3T Diffusion Tensor Imaging of Mild Traumatic Brain Injury: A Prospective Longitudinal Study. Proc ISMRM 2009; 641.

  BACKGROUND

• Niogi SN, Mukherjee P, Ghajar J, Johnson CE, Kolster R, Lee H, Suh M, Zimmerman RD, Manley GT, McCandliss BD. Structural dissociation of attentional control and memory in adults with and without mild traumatic brain injury. Brain. 2008 Dec;131(Pt 12):3209-21. doi: 10.1093/brain/awn247. Epub 2008 Oct 24.

  PMID: 18952679 BACKGROUND

• Saatman KE, Duhaime AC, Bullock R, Maas AI, Valadka A, Manley GT; Workshop Scientific Team and Advisory Panel Members. Classification of traumatic brain injury for targeted therapies. J Neurotrauma. 2008 Jul;25(7):719-38. doi: 10.1089/neu.2008.0586.

  PMID: 18627252 BACKGROUND

• Steyerberg EW, Mushkudiani N, Perel P, Butcher I, Lu J, McHugh GS, Murray GD, Marmarou A, Roberts I, Habbema JD, Maas AI. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. 2008 Aug 5;5(8):e165; discussion e165. doi: 10.1371/journal.pmed.0050165.

  PMID: 18684008 BACKGROUND

• Rusnak M, Janciak I, Majdan M, Wilbacher I, Mauritz W; Australian Severe TBI Study Investigators. Severe traumatic brain injury in Austria VI: effects of guideline-based management. Wien Klin Wochenschr. 2007 Feb;119(1-2):64-71. doi: 10.1007/s00508-006-0765-0.

  PMID: 17318752 BACKGROUND

• Wakana S, Caprihan A, Panzenboeck MM, Fallon JH, Perry M, Gollub RL, Hua K, Zhang J, Jiang H, Dubey P, Blitz A, van Zijl P, Mori S. Reproducibility of quantitative tractography methods applied to cerebral white matter. Neuroimage. 2007 Jul 1;36(3):630-44. doi: 10.1016/j.neuroimage.2007.02.049. Epub 2007 Mar 20.

  PMID: 17481925 BACKGROUND

• Yuh EL, Gean AD, Manley GT, Callen AL, Wintermark M. Computer-aided assessment of head computed tomography (CT) studies in patients with suspected traumatic brain injury. J Neurotrauma. 2008 Oct;25(10):1163-72. doi: 10.1089/neu.2008.0590.

  PMID: 18986221 BACKGROUND

• Yue JK, Kobeissy FH, Jain S, Sun X, Phelps RRL, Korley FK, Gardner RC, Ferguson AR, Huie JR, Schneider ALC, Yang Z, Xu H, Lynch CE, Deng H, Rabinowitz M, Vassar MJ, Taylor SR, Mukherjee P, Yuh EL, Markowitz AJ, Puccio AM, Okonkwo DO, Diaz-Arrastia R, Manley GT, Wang KKW. Neuroinflammatory Biomarkers for Traumatic Brain Injury Diagnosis and Prognosis: A TRACK-TBI Pilot Study. Neurotrauma Rep. 2023 Mar 24;4(1):171-183. doi: 10.1089/neur.2022.0060. eCollection 2023.

  PMID: 36974122 DERIVED

• Yue JK, Cnossen MC, Winkler EA, Deng H, Phelps RRL, Coss NA, Sharma S, Robinson CK, Suen CG, Vassar MJ, Schnyer DM, Puccio AM, Gardner RC, Yuh EL, Mukherjee P, Valadka AB, Okonkwo DO, Lingsma HF, Manley GT; TRACK-TBI Investigators. Pre-injury Comorbidities Are Associated With Functional Impairment and Post-concussive Symptoms at 3- and 6-Months After Mild Traumatic Brain Injury: A TRACK-TBI Study. Front Neurol. 2019 Apr 9;10:343. doi: 10.3389/fneur.2019.00343. eCollection 2019.

  PMID: 31024436 DERIVED

• Ranson J, Magnus BE, Temkin N, Dikmen S, Giacino JT, Okonkwo DO, Valadka AB, Manley GT, Nelson LD; TRACK-TBI Investigators. Diagnosing the GOSE: Structural and Psychometric Properties Using Item Response Theory, a TRACK-TBI Pilot Study. J Neurotrauma. 2019 Sep 1;36(17):2493-2505. doi: 10.1089/neu.2018.5998. Epub 2019 May 23.

  PMID: 30907261 DERIVED

• Yue JK, Winkler EA, Sharma S, Vassar MJ, Ratcliff JJ, Korley FK, Seabury SA, Ferguson AR, Lingsma HF, Deng H, Meeuws S, Adeoye OM, Rick JW, Robinson CK, Duarte SM, Yuh EL, Mukherjee P, Dikmen SS, McAllister TW, Diaz-Arrastia R, Valadka AB, Gordon WA, Okonkwo DO, Manley GT; the TRACK-TBI Investigators. Temporal profile of care following mild traumatic brain injury: predictors of hospital admission, follow-up referral and six-month outcome. Brain Inj. 2017;31(13-14):1820-1829. doi: 10.1080/02699052.2017.1351000.

  PMID: 29166203 DERIVED

• Nelson LD, Ranson J, Ferguson AR, Giacino J, Okonkwo DO, Valadka AB, Manley GT, McCrea MA. Validating Multi-Dimensional Outcome Assessment Using the Traumatic Brain Injury Common Data Elements: An Analysis of the TRACK-TBI Pilot Study Sample. J Neurotrauma. 2017 Nov 15;34(22):3158-3172. doi: 10.1089/neu.2017.5139. Epub 2017 Aug 17.

  PMID: 28595478 DERIVED

• Nielson JL, Cooper SR, Yue JK, Sorani MD, Inoue T, Yuh EL, Mukherjee P, Petrossian TC, Paquette J, Lum PY, Carlsson GE, Vassar MJ, Lingsma HF, Gordon WA, Valadka AB, Okonkwo DO, Manley GT, Ferguson AR; TRACK-TBI Investigators. Uncovering precision phenotype-biomarker associations in traumatic brain injury using topological data analysis. PLoS One. 2017 Mar 3;12(3):e0169490. doi: 10.1371/journal.pone.0169490. eCollection 2017.

  PMID: 28257413 DERIVED

• Yue JK, Winkler EA, Rick JW, Burke JF, McAllister TW, Oh SS, Burchard EG, Hu D, Rosand J, Temkin NR, Korley FK, Sorani MD, Ferguson AR, Lingsma HF, Sharma S, Robinson CK, Yuh EL, Tarapore PE, Wang KK, Puccio AM, Mukherjee P, Diaz-Arrastia R, Gordon WA, Valadka AB, Okonkwo DO, Manley GT; TRACK-TBI Investigators. DRD2 C957T polymorphism is associated with improved 6-month verbal learning following traumatic brain injury. Neurogenetics. 2017 Jan;18(1):29-38. doi: 10.1007/s10048-016-0500-6. Epub 2016 Nov 8.

  PMID: 27826691 DERIVED

• Winkler EA, Yue JK, McAllister TW, Temkin NR, Oh SS, Burchard EG, Hu D, Ferguson AR, Lingsma HF, Burke JF, Sorani MD, Rosand J, Yuh EL, Barber J, Tarapore PE, Gardner RC, Sharma S, Satris GG, Eng C, Puccio AM, Wang KK, Mukherjee P, Valadka AB, Okonkwo DO, Diaz-Arrastia R, Manley GT; TRACK-TBI Investigators. COMT Val 158 Met polymorphism is associated with nonverbal cognition following mild traumatic brain injury. Neurogenetics. 2016 Jan;17(1):31-41. doi: 10.1007/s10048-015-0467-8. Epub 2015 Nov 17.

  PMID: 26576546 DERIVED

• McMahon PJ, Panczykowski DM, Yue JK, Puccio AM, Inoue T, Sorani MD, Lingsma HF, Maas AI, Valadka AB, Yuh EL, Mukherjee P, Manley GT, Okonkwo DO; TRACK-TBI Investigators. Measurement of the glial fibrillary acidic protein and its breakdown products GFAP-BDP biomarker for the detection of traumatic brain injury compared to computed tomography and magnetic resonance imaging. J Neurotrauma. 2015 Apr 15;32(8):527-33. doi: 10.1089/neu.2014.3635. Epub 2015 Jan 26.

  PMID: 25264814 DERIVED

• Lingsma HF, Yue JK, Maas AI, Steyerberg EW, Manley GT; TRACK-TBI Investigators. Outcome prediction after mild and complicated mild traumatic brain injury: external validation of existing models and identification of new predictors using the TRACK-TBI pilot study. J Neurotrauma. 2015 Jan 15;32(2):83-94. doi: 10.1089/neu.2014.3384. Epub 2014 Nov 25.

  PMID: 25025611 DERIVED

• Ratcliff JJ, Adeoye O, Lindsell CJ, Hart KW, Pancioli A, McMullan JT, Yue JK, Nishijima DK, Gordon WA, Valadka AB, Okonkwo DO, Lingsma HF, Maas AI, Manley GT; TRACK-TBI investigators. ED disposition of the Glasgow Coma Scale 13 to 15 traumatic brain injury patient: analysis of the Transforming Research and Clinical Knowledge in TBI study. Am J Emerg Med. 2014 Aug;32(8):844-50. doi: 10.1016/j.ajem.2014.04.003. Epub 2014 Apr 13.

  PMID: 24857248 DERIVED

• McMahon P, Hricik A, Yue JK, Puccio AM, Inoue T, Lingsma HF, Beers SR, Gordon WA, Valadka AB, Manley GT, Okonkwo DO; TRACK-TBI Investigators. Symptomatology and functional outcome in mild traumatic brain injury: results from the prospective TRACK-TBI study. J Neurotrauma. 2014 Jan 1;31(1):26-33. doi: 10.1089/neu.2013.2984. Epub 2013 Oct 31.

  PMID: 23952719 DERIVED

• Dams-O'Connor K, Spielman L, Singh A, Gordon WA, Lingsma HF, Maas AI, Manley GT, Mukherjee P, Okonkwo DO, Puccio AM, Schnyer DM, Valadka AB, Yue JK, Yuh EL; TRACK-TBI Investigators. The impact of previous traumatic brain injury on health and functioning: a TRACK-TBI study. J Neurotrauma. 2013 Dec 15;30(24):2014-20. doi: 10.1089/neu.2013.3049. Epub 2013 Oct 23.

  PMID: 23924069 DERIVED

• Diaz-Arrastia R, Wang KK, Papa L, Sorani MD, Yue JK, Puccio AM, McMahon PJ, Inoue T, Yuh EL, Lingsma HF, Maas AI, Valadka AB, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Acute biomarkers of traumatic brain injury: relationship between plasma levels of ubiquitin C-terminal hydrolase-L1 and glial fibrillary acidic protein. J Neurotrauma. 2014 Jan 1;31(1):19-25. doi: 10.1089/neu.2013.3040. Epub 2013 Oct 9.

  PMID: 23865516 DERIVED

• Yue JK, Vassar MJ, Lingsma HF, Cooper SR, Okonkwo DO, Valadka AB, Gordon WA, Maas AI, Mukherjee P, Yuh EL, Puccio AM, Schnyer DM, Manley GT; TRACK-TBI Investigators. Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury. J Neurotrauma. 2013 Nov 15;30(22):1831-44. doi: 10.1089/neu.2013.2970. Epub 2013 Sep 24.

  PMID: 23815563 DERIVED

• Okonkwo DO, Yue JK, Puccio AM, Panczykowski DM, Inoue T, McMahon PJ, Sorani MD, Yuh EL, Lingsma HF, Maas AI, Valadka AB, Manley GT; Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Investigators. GFAP-BDP as an acute diagnostic marker in traumatic brain injury: results from the prospective transforming research and clinical knowledge in traumatic brain injury study. J Neurotrauma. 2013 Sep 1;30(17):1490-7. doi: 10.1089/neu.2013.2883. Epub 2013 Aug 1.

  PMID: 23489259 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for genetic analysis. Plasma for proteomic analysis.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Psychological Well-Being

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Limitations and Caveats

Enrolling patients representative of the TBI population created challenges for follow-up (e.g. homelessness, substance abuse); limited access to research MRI scanner; lack of validated outcome measures for non-English-speaking and pediatric patients.

Results Point of Contact

• Title: Geoffrey Manley, MD, PhD
• Organization: University of California, San Francisco

manleyg@neurosurg.ucsf.edu

415-206-8300

Study Officials

• Geoffrey T Manley, MD, PhD

  University of California, San Francisco (San Francisco, CA)

  PRINCIPAL INVESTIGATOR

• David O Okonkwo, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Alex B Valadka, MD

  University Medical Center, Brackenridge (Austin, TX)

  PRINCIPAL INVESTIGATOR

• Wayne A Gordon, PhD

  Mount Sinai Rehabilitation Center (New York, NY)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 24, 2012
• First Posted: March 28, 2012
• Study Start: April 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2013
• Last Updated: February 17, 2014
• Results First Posted: February 17, 2014

Record last verified: 2014-01

Locations

US (4)