Transforming Research and Clinical Knowledge in TBI Pilot
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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:
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 ]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 |
| 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
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
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | March 24, 2012 |
| Results First Received: | January 3, 2014 |
| Last Updated: | January 3, 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:
|
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 May 23, 2017