Transforming Research and Clinical Knowledge in TBI Pilot
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01565551 |
Recruitment Status :
Completed
First Posted : March 28, 2012
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
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Condition or disease | Intervention/treatment |
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Traumatic Brain Injury | Other: N/A (Observational Study) |

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 |

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).
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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).
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Other: N/A (Observational Study)
No Interventions: Observational Study |
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
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 | |
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) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01565551 |
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 |
Traumatic Brain Injury Common Data Elements Prognostic Models Neuroimaging |
Biomarkers Genetic Variants Concussion Psychological Health |
Brain Injuries Brain Injuries, Traumatic Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |