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Transforming Research and Clinical Knowledge in TBI Pilot

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01565551
First received: March 24, 2012
Last updated: January 3, 2014
Last verified: January 2014
History of Changes
  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. 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 Intervention
Traumatic Brain Injury
 Other: N/A (Observational Study)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Glasgow Outcome Scale Extended (GOSE) [ Time Frame: 6 Months Post-Injury ] [ Designated as safety issue: No ]
    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.

Enrollment: 650
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: March 24, 2012
Results First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 30, 2016