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NCT01565551 · ClinicalTrials.gov registry record
Transforming Research and Clinical Knowledge in TBI Pilot
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 650
- Enrollment target
NCT01565551: Completed study, sponsored by University of California, San Francisco.
NCT01565551 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 650 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565551 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 650 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- OTHER N/A (Observational Study)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-12 |
What the finished NCT01565551 record still lists
NCT01565551 is an observational study that tracks outcomes without assigning an intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which N/A (Observational Study) is the first listed.
NCT01565551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01565551 about?
NCT01565551 is a clinical study titled "Transforming Research and Clinical Knowledge in TBI Pilot". 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 wi...
What is the current status of trial NCT01565551?
This trial is currently completed. The enrollment target is 650 participants. The study started on 2010-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01565551?
The interventions under investigation include: N/A (Observational Study) (OTHER).
Who is sponsoring clinical trial NCT01565551?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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