tracktbi.ucsf.eduTransforming Research and Clinical Knowledge in TBI | TRACK-TBI
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You are using an outdated browser. Please upgrade your browser or activate Google Chrome Frame to improve your experience. Skip to main content University of California, San Francisco About UCSF Search UCSF UCSF Medical Center TRACK-TBI Mobile Navigation Search form Search About TRACK-TBI Events Organization and Leadership Clinical & Analytic Sites Support Contact The TBI Friend Control Study TRACK-TBI LONG Cores Administrative Core Biospecimens Core Biostatistical and Comparative Effectiveness Research Core Clinical Core Informatics Core Neuroimaging Core Outcomes Core Working Groups Emergency Medicine Group Geriatric TBI Group ICU TBI Group Pediatrics TBI Group Publications Collaboration Opportunities Resources For Patients For Researchers Partners One Mind Philanthropic & Government Partners Industry Partners News Transforming Research and Clinical Knowledge in TBI Print PDF Traumatic Brain Injury (TBI) is a condition, not a one-time event. Effective treatment of TBI represents a great unmet need in public health. In 2013, approximately 2.8 million TBI-related emergency department (ED) visits, hospitalizations, and deaths occurred in the United States. TBI is a contributing factor in a third of all injury-related US deaths. An estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and psychological health disabilities of TBI, with annual direct and indirect costs estimated at over $76 billion. Although we are gaining ground in our understanding of the pathophysiology of TBI, these advances have failed to translate into a single successful clinical trial or treatment . The NINDS-funded, multicenter Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study aims to change this. In collaboration with expert public-private partners, we are collecting and analyzing detailed clinical data on subjects at 18 U.S. sites, across the injury spectrum, along with CT/MRI imaging, blood biospecimens, and detailed clinical outcomes. TRACK-TBI has currently enrolled over 2,700 TBI patients on the path to reach its enrollment goal of 3,000 by the end of the study. This rich and diverse precision medicine dataset will reside in a publicly accessible infrastructure of integrated databases, imaging repositories, and biosample repositories – a true TBI Information Commons. Our high quality and fully integrated TBI-Common Data Element dataset will provide a global platform to connect TBI’s best scientists. READ MORE TRACK-TBI is built from the foundational NINDS-funded TRACK-TBI Pilot study , which collected clinical data from 3 sites and 600 subjects. With over a dozen publications and growing, the TRACK-TBI Pilot dataset is the first to populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository and with the current TRACK-TBI data, is compatible with the International Initiative for Traumatic Brain Injury Research (InTBIR), a collaborative effort of the European Commission (EC), the Canadian Institutes of Health Research (CIHR) and the National Institutes of Health (NIH). TRACK-TBI also forms one of the core datasets of the Department of Defense-funded TBI Endpoints Development (TED) Initiative, which has established an interrogatable Metadataset of high quality studies across civilian, sports, and military populations. TED’s goals, aligned with TRACK-TBI, are to identify and validate the FDA regulatory readiness of candidate clinical outcome assessments and proteomic and neuroimaging biomarkers and technologies that may serve as endpoints in the design of precision clinical trials. The TRACK-TBI fully integrated TBI Information Commons will: Improve TBI classification/taxonomy for targeted clinical treatment trials Improve TBI outcome assessments, such that the size and costs of clinical trials can be reduced Identify the health and economic impact of Mild TBI patient disposition Create a legacy database with analytic tools and resources to support TBI research Our expected outcome for this international resource is to identify new diagnostic and prognostic markers and refine outcome assessments, which will lead to successful clinical treatment trials. TRACK-TBI Enrollment Count 3,691 persons with TBI and control subjects enrolled as of February 7, 2020. News LISTEN: UCSF Researches Simple Blood Test to Detect Concussions TRACK-TBI LONG Launches TED Initiative Receives FDA Qualification of Medical Device Development Tool See all TED Receives 2nd FDA Letter of Support On January 10, 2018, the TED Initiative, along with TRACK-TBI, received an FDA Letter of Support (LOS) to encourage the further study of blood levels of glial fibrillary acidic protein (GFAP), a biomarker of astrocytic injury and ubiquitin carboxyl-terminal hydrolase-L1 (UCH-L1), a biomarker of neuronal injury, as exploratory prognostic enrichment biomarkers to identify patients who are at risk for having poor functional outcome during the course of TBI clinical trials. Issued by FDA's Office of New Drugs, the LOS highlights the FDA’s endorsement of our approach to leveraging data across studies, paying particular attention to the use of data standards, data sharing, and analytic processes. This complements the LOS received last year to explore neuroimaging prognostic biomarkers. To date, these are the only two Letters of Support issued by FDA related to traumatic brain injury. Learn More About the TED Initiative The TBI Endpoints Development (TED) Initiative is a 5-year award funded by the Department of Defense with a key objective to advance the design of clinical trials that will lead to the first successful treatments of acute TBI. Visit the TED website for learn more. Subscribe to our mailing list Brain and Spinal Injury Center | UCSF 1001 Potrero Avenue, Building 1, Room 101 San Francisco, CA 94110 Phone: (415) 206-8300 Fax: (415) 206-3948 UCSF Main Site © 2014 The Regents of the University of California...