TRACK-TBI Pilot Initiative

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Grant No: RC2NS069409

Coordinating Center: University of California, San Francisco

Purpose:

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. The investigators anticipate that this project has the potential to substantially advance and revolutionize clinical research in TBI. Repositories for neuroimaging, proteomic, and genetic biomarkers will facilitate the evolving field of these emerging technologies in TBI.

Testing and validating of TBI-CDEs will be performed in a multi-center prospective observational study with 3 Acute TBI Centers and 1 Rehabilitation Center:

Study Sites	Principal Investigator
UCSF, San Francisco General Hospital	Geoffrey Manley, MD, PhD
University of Pittsburgh Medical Center	David Okonkwo, MD, PhD
University Medical Center Brackenridge	Alex Valadka, MD
Mount Sinai Rehabilitation Center	Wayne Gordon, PhD

Inclusion Criteria:

Presentation to emergency department < 24 hours post-injury
Head CT scan for TBI as part of regular care
English speaking (outcome measures have not been normed for non-English)

Study Components (Ref: NIH-NINDS TBI Common Data Elements):

1. Clinical care, demographic and outcome data collection.

2. Blood draws for proteomic and genetic marker analyses.

3. 3T Magnetic Resonance Imaging will be completed on a subset of patients able to return 1-2 weeks post-injury.

4. Three month follow up. The Glasgow Outcome Scale - Extended (GOS-E) and neurological symptoms inventory will be administered to patients over the phone 3 months post-injury.

5. Six, twelve and twenty-four month neurocognitive assessments. Standardized measures from all designated CORE domains for outcome after TBI by the CDEs which include:

Global recovery
Functional outcome
Psychological impairment
Post-traumatic stress disorder (PTSD)
Quality of life

TRACK-TBI Publications:

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, Gordon WA, Valadka AB, Okonkwo DO, Manley GT; 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 Nov 22. Epub ahead of print. https://doi.org/10.1080/02699052.2017.1351000.

Yue JK, Robinson CK, Burke JF, Winkler EA, Deng H, Cnossen MC, Lingsma HF, Ferguson AR, McAllister TW, Rosand J, Burchard EG, Sorani MD, Sharma S, Nielson JL, Satris GG, Talbott JF, Tarapore PE, Korley FK, Wang KKW, Yuh EL, Mukherjee P, Diaz-Arrastia R, Valadka AB, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Apolipoprotein E epsilon 4 (APOE-ε4) genotype is associated with decreased 6-month verbal memory performance after mild traumatic brain injury. Brain Behav. 2017 Aug 9;7(9):e00791. PMID 28948085.

Yue JK, Ngwenya LB, Upadhyayula PS, Deng H, Winkler EA, Burke JF, Lee YM, Robinson CK, Ferguson AR, Lingsma HF, Cnossen MC, Pirracchio R, Korley FK, Vassar MJ, Yuh EL, Mukherjee P, Gordon WA, Valadka AB, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Emergency department blood alcohol level associates with injury factors and six-month outcome after uncomplicated mild traumatic brain injury. J Clin Neurosci. 2017 Nov;45:293-298. PMID 28789959.

Rubenstein R, Chang B, Yue JK, Chiu A, Winkler EA, Puccio AM, Diaz-Arrastia R, Yuh EL, Mukherjee P, Valadka AB, Gordon WA, Okonkwo DO, Davies P, Agarwal S, Fan L, Sarkis G, Yadikar H, Yang Z, Manley GT, Wang KKW; TRACK-TBI Investigators. Comparing plasma phospho tau, total tau and phospho tau-total tau ratio as acute and chronic traumatic brain injury biomarkers. JAMA Neurol. 2017;74(9):1063-1073. PMID 28738126.

Nelson LD, Ranson J, Ferguson AR, Giacino JT, Okonkwo DO, Valadka AB, Manley GT, McCrea MA; TRACK-TBI Investigators. Validating multidimensional outcome assessment using the TBI Common Data Elements: An analysis of the TRACK-TBI Pilot sample. J Neurotrauma. 2017 Jun 8. Epub ahead of print. PMID 28595478.

Manley GT, MacDonald CL, Markowitz AJ, Stephenson D, Robbins A, Gardner RC, Winkler EA, Bodien YG, Taylor SR, Yue JK, Kannan L, Kumar A, McCrea MA, Wang KKW; TED Investigators. The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a public-private regulatory collaboration to accelerate diagnosis and treatment of traumatic brain injury. J Neurotrauma. 2017 Mar 31. Epub ahead of print. PMID 28363253.

Cnossen MC*, Winkler EA*, Yue JK, Okonkwo DO, Valadka AB, Steyerberg EW, Lingsma HF, Manley GT; TRACK-TBI Investigators. Development of a prediction model for post-concussive symptoms following mild traumatic brain injury: A TRACK-TBI Pilot study. J Neurotrauma. 2017 Aug 15;34(16):2396-2409. PMID 28343409.

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. PMID 28257413.

Palacios EM, Yuh EL, Chang YS, Yue JK, Schnyer DM, Okonkwo DO, Valadka AB, Gordon WA, Maas AI, Vassar MJ, Manley GT, Mukherjee P. Resting state functional connectivity alterations associated with six-month outcomes in mild traumatic brain injury. J Neurotrauma. 2017 Apr 15;34(8):1546-1557. PMID 28085565.

Palacios EM, Martin AJ, Boss MA, Ezekiel F, Chang YS, Yuh EL, Vassar MJ, Schnyer DM, MacDonald CL, Crawford KL, Irimia A, Toga AW, Mukherjee P; TRACK-TBI Investigators. Toward precision and reproducibility of diffusion tensor imaging: A multicenter diffusion phantom and traveling volunteer study. AJNR Am J Neuroradiol. 2017 Mar;38(3):537-545. PMID 28007768.

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 KKW, 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. PMID 27826691.

Winkler EA*, Yue JK*, Ferguson AR, Temkin NR, Stein MB, Barber J, Yuh EL, Sharma S, Satris GG, McAllister TW, Rosand J, Sorani MD, Lingsma HF, Vassar MJ, Tarapore PE, Burchard EG, Hu D, Eng C, Puccio AM, Wang KKW, Mukherjee P, Okonkwo DO, Diaz-Arrastia R, Manley GT; TRACK-TBI Investigators. COMT Val158Met polymorphism is associated with post-traumatic stress disorder and functional outcome following mild traumatic brain injury. J Clin Neurosci. 2017 Jan;35:109-116. PMID 27769642.

Pirracchio R, Yue JK, Manley GT, van der Laan MJ, Hubbard AE; TRACK-TBI Investigators. Collaborative targeted maximum likelihood estimation for variable importance measure: Illustration for functional outcome prediction in mild traumatic brain injuries. Stat Methods Med Res. 2016 Jun 29. Epub ahead of print. PMID 27363429.

Wang KKW*, Yang Z*, Yue JK*, Zhang Z, Winkler EA, Puccio AM, Diaz-Arrastia R, Lingsma HF, Yuh EL, Mukherjee P, Valadka AB, Gordon WA, Okonkwo DO, Manley GT; TRACK-TBI Investigators. Plasma anti-glial fibrillary acidic protein autoantibody levels during the acute and chronic phases of traumatic brain injury – A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot study. J Neurotrauma. 2016 Jul 1;33(13):1270-1277. PMID 26560343.

Haarbauer-Krupa J, Taylor CA, Yue JK, Winkler EA, Pirracchio R, Cooper SR, Burke JF, Stein MB, Manley GT; TRACK-TBI Investigators. Screening for post-traumatic stress disorder in a civilian emergency department population with traumatic brain injury. J Neurotrauma. 2017 Jan 1;34(1):50-58. PMID 26936513.

Korley FK, Diaz-Arrastia R, Wu AH, Yue JK, Manley GT, Sair HI, Van Eyk J, Everett AD; TRACK-TBI Investigators. Circulating brain-derived neurotrophic factor has diagnostic and prognostic value in traumatic brain injury. J Neurotrauma. 2016 Jan 15;33(2):215-225. PMID 26159676.

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. PMID 26576546.

Yue JK*, Pronger AM*, Ferguson AR, Temkin NR, Sharma S, Rosand J, Sorani MD, McAllister TW, Barber J, Winkler EA, Burchard EG, Hu D, Lingsma HF, Cooper SR, Puccio AM, Okonkwo DO, Diaz-Arrastia R, Manley GT; COBRIT Investigators; TRACK-TBI Investigators. Association of a common genetic variant within ANKK1 with six-month cognitive performance after traumatic brain injury. Neurogenetics. 2015 Jul;16(3):169-180. PMID 25633559.

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):527-533. PMID 25264814.

Sorani MD, Yue JK, Sharma S, Manley GT, Ferguson AR; TRACK-TBI Investigators. Genetic data sharing and privacy. Neuroinformatics. 2015 Jan;13(1):1-6. PMID 25326433.

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. PMID 25025611.

Yuh EL, Cooper SR, Mukherjee P, Yue JK, Lingsma HF, Gordon WA, Valadka AB, Okonkwo DO, Schnyer DM, Vassar MJ, Maas AI, Manley GT; TRACK-TBI Investigators. Diffusion tensor imaging for outcome prediction in complicated and uncomplicated mild traumatic brain injury: A TRACK-TBI study. J Neurotrauma. 2014 Sep 1;31(17):1457-1477. PMID 24742275.

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. Emergency department disposition of the GCS 13-15 traumatic brain injury patient: Analysis of the TRACK-TBI study. Am J Emergency Med. 2014 Aug;32(8):844-850. PMID 24857248.

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. PMID 23952719.

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. PMID 23865516.

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):2014-2020. PMID 23924069.

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):1831-1844. PMID 23815563.

Okonkwo DO, Yue JK, Puccio AM, Panczykowski DM, Inoue T, McMahon PJ, Sorani MD, Yuh EL, Lingsma HF, Maas AI, Valadka AB, Manley GT; 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):1490-1497. PMID 23489259.

Yuh EL, Mukherjee P, Lingsma HF, Yue JK, Ferguson AR, Gordon WA, Valadka AB, Schnyer DM, Okonkwo DO, Maas AI, Manley GT; TRACK-TBI Investigators. MRI improves 3-month outcome prediction in mild traumatic brain injury. Ann Neurol. 2013 Feb;73(2):224-235. PMID 23224915.

Additional Information:

Detailed Study Protocol at ClinicalTrials.gov: NCT01565551

NIH-NINDS Common Data Elements for Traumatic Brain Injury

For more information contact:

John K. Yue, CCRC, PMP

Clinical Trial Manager

[email protected]

References:

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.

Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Study Components

Study Components

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