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ACTIVE NOT RECRUITING
NCT04602806

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.

Official title: TRACK-TBI Precision Medicine Phase 2-Option I

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2021-06-01

Completion Date

2030-04-09

Last Updated

2025-04-13

Healthy Volunteers

No

Locations (5)

University of California, San Francisco

San Francisco, California, United States

University of Pennsylvania/Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States