TRACK-TBI Multicenter 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

Additional Information:

Detailed Study Protocol at ClinicalTrials.gov: NCT01565551

NIH-NINDS Common Data Elements for Traumatic Brain Injury

For more information contact:

Research Coordinator

yuej@neurosurg.ucsf.edu

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. Review.

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

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. Epub 2008 Feb 12.

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. Epub 2008 Oct 24.

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; discussion 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. Epub 2007 Mar 20.

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
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