Transforming Research and Clinical Knowledge in TBI Pilot

Completed

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT01565551

Run by

University of California, San Francisco

People needed

650

Starts

2010-04-01

Expected to finish

2013-12-01

Last updated by the study team

2014-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presentation to Emergency Department < 24 hours post-injury
• Head CT scan for Traumatic Brain Injury (TBI) as part of regular care.
• English Speaking

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital (SFGH) — San Francisco, California, United States
• Mount Sinai Rehabilitation Center — New York, New York, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• University Medical Center, Brackenridge — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.