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Transforming Research and Clinical Knowledge in TBI Pilot

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ClinicalTrials.gov Identifier: NCT01565551
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Other: N/A (Observational Study)

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Study Design
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Study Type : Observational
Actual Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot
Study Start Date : April 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Glasgow Outcome Scale Extended (GOSE) [ Time Frame: 6 Months Post-Injury ]
    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.


Biospecimen Retention:   Samples With DNA
Whole blood for genetic analysis. Plasma for proteomic analysis.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Presentation to Emergency Department > 24 hours post-injury
  • Custody or Incarceration
  • 5150 Psychiatric Hold

Component-Specific Exclusion Criteria:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565551


Locations
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
Sponsors and Collaborators
University of California, San Francisco
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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
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)
More Information
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Publications:
Finkelstein E, Corso P, Miller T. The Incidence and Economic Burden of Injuries in the United States. New York, NY: Oxford University Press; 2006.
Foulkes AM, Eisenberg MH, Jane AJ. The Traumatic Coma Data Bank; design, methods and baseline characteristics. J. Neuroch. 75, S1-S15, 1991
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01565551     History of Changes
Other Study ID Numbers: RC2NS069409 ( U.S. NIH Grant/Contract )
RC2NS069409 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2012    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014
Last Verified: January 2014

Keywords provided by University of California, San Francisco:
Traumatic Brain Injury
Common Data Elements
Prognostic Models
Neuroimaging
 Biomarkers
Genetic Variants
Concussion
Psychological Health

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries