Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Transforming Research and Clinical Knowledge in Traumatic Brain Injury|
- N/A (Observational Study) [ Time Frame: N/A (Observational Study) ] [ Designated as safety issue: No ]Please Refer to Study Components for measures employed in this study.
Biospecimen Retention: Samples With DNA
Whole blood for genetic analysis. Plasma for proteomic analysis.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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)
No Interventions: 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)
No Interventions: Observational Study
Hide Detailed Description
The Investigators aim for a 10-month data collection period for TBI patients across the spectrum from concussion to coma with a limited 3-month follow up and extensive 6-, 12-, and 24-month follow ups. Patient enrollment will occur in three high-volume TBI Centers (SFGH, UPMC, UMCB) and a TBI Rehabilitation Center (MSMC). These Centers have a long track record of multi-center TBI research experience as well as existing infrastructure for rapid start-up and sustained enrollment. All patients admitted acutely with a history of external force injury to the head with a head CT performed in the emergency department are eligible for enrollment. Head CTs are performed according to the American College of Emergency Physicians (ACEP) and the Centers for Disease Control and Prevention (CDC) Guidelines for neuroimaging and decision making in TBI. These Guidelines are already in place at the participating Centers and are used to determine which patients will receive a non-contrast head CT scan as part of their initial evaluation. Patients will not be excluded based on age, race, gender, ethnicity, substance abuse, or prior psychiatric history to provide a population-based sample of of TBI subjects across the injury spectrum from concussion to coma.
Study Components (Ref: NIH-NINDS TBI Common Data Elements):
- Clinical Care and Demographic Data Collection. Variables include: date and time of injury, mechanism of injury, acute laboratory values and vital signs, neurological evaluations, surgical interventions, hospital course, morbidity and mortality during acute care.
- Blood Draw for Proteomic and Genetic Marker Analyses. Blood samples will be drawn within 24 hours of injury. Plasma will be spun and separated from whole blood. Both plasma and whole blood samples will be banked centrally under -80 degrees Celsius at the University of California, San Francisco (UCSF) DNA Bank.
- 3-Tesla (3T) Magnetic Resonance Imaging. A 3T Research MRI will be completed on a subset of patients able to return 1-2 weeks post-injury.
- 3-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.
- 6-, 12-, and 24-Month Neurocognitive Assessment. Standardized measures from all designated CORE domains for outcome after TBI by TBI-CDEs, which include: global recovery, functional outcome, psychological impairment, post-traumatic stress disorder (PTSD), and quality of life, will be administered to the participant.
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.
Yue JK, Vassar MJ, Lingsma H, Cooper SR, Yuh EL, Mukherjee P, Puccio AM, Gordon W, Okonkwo DO, Valadka A, Schnyer DM, Maas A, Manley GT, TRACK-TBI Investigators. Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury. J Neurotrauma. 2013 Jul 2 [Epub ahead of print].
Diaz-Arrastia R, Wang KK, Papa L, Sorani MD, Yue JK, Puccio AM, McMahon PJ, Inoue T, Yuh EL, Lingsma H, Maas A, Valadka A, Okonkwo DO, Manley GT, TRACK-TBI Investigators. Acute Biomarkers of Traumatic Brain Injury: Relationship Between Plasma Levels of Ubiquitin C-Terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP). J Neurotrauma. 2013 Jul 18 [Epub ahead of print].
Okonkwo DO, Yue JK, Puccio AM, Panczykowski D, Inoue T, McMahon PJ, Sorani MD, Yuh EL, Lingsma H, Maas A, Valadka A, Manley GT, TRACK-TBI Investigators. GFAP-BDP as an Acute Diagnostic Marker of Traumatic Brain Injury: Results from the Prospective TRACK-TBI Study. J Neurotrauma. 2013 Mar 14 [Epub ahead of print].
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. Magnetic Resonance Imaging Improves 3-Month Outcome Prediction in Mild Traumatic Brain Injury. Ann Neurol. 2013 Feb;73(2):224-35.
|United States, California|
|San Francisco General Hospital (SFGH)|
|San Francisco, California, United States, 94110|
|United States, New York|
|Mount Sinai Rehabilitation Center|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center (UPMC)|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|University Medical Center, Brackenridge|
|Austin, Texas, United States, 78701|
|Principal Investigator:||Geoffrey T Manley, MD, PhD||University of California, San Francisco (San Francisco, CA)|
|Principal Investigator:||David O Okonkwo, MD, PhD||University of Pittsburgh Medical Center (Pittsburgh, PA)|
|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)|