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

NCT04602806 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-04-13

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

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

  • Claudia S Robertson, MD · Baylor College of Medicine

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

  • Ramon Diaz-Arrastia, MD, PhD · University of Pennsylvania

  • Nancy R Temkin, PhD · University of Washington

  • Pratik Mukherjee, MD, PhD · University of California, San Francisco

  • Joseph T Giacino, PhD · Harvard Medical School, Spaulding Rehabilitation Hospital

  • Murray B Stein, MD, MPH · University of California, San Diego

  • Mike McCrea, PhD, ABPP · Medical College of Wisconsin

  • Ramesh Grandhi, MD, MS · University of Utah

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-11-11
Completion
2030-04-09

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 NCT04602806 on ClinicalTrials.gov