N/A
N=637
Transforming Research and Clinical Knowledge in TBI Pilot
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01565551 ↗Enrolled (actual)
637
Serious AEs
—
Results posted
Feb 2014
Primary outcome: Primary: Glasgow Outcome Scale Extended (GOSE) — 7; 5 Glasgow Outcome Scale Extended (GOSE)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- N/A (Observational Study) (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glasgow Outcome Scale Extended (GOSE) |
7; 5 | — |
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.
Eligibility Criteria
Inclusion 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.
Data sourced from ClinicalTrials.gov (NCT01565551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.