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Transforming Research and Clinical Knowledge in TBI Pilot

NCT01565551 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2014-02-17

Study results available
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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.

Conditions

Interventions

OTHER

N/A (Observational Study)

No Interventions: Observational Study

Sponsors & Collaborators

Principal Investigators

  • Geoffrey T Manley, MD, PhD · University of California, San Francisco (San Francisco, CA)

  • David O Okonkwo, MD, PhD · University of Pittsburgh

  • Alex B Valadka, MD · University Medical Center, Brackenridge (Austin, TX)

  • Wayne A Gordon, PhD · Mount Sinai Rehabilitation Center (New York, NY)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-08-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565551 on ClinicalTrials.gov