Clinical trialNCT04602806Active, not recruitingObservational

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

SponsorUniversity of California, San FranciscoEnrollment50Traumatic Brain Injury

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Claudia S Robertson, MD
Baylor College of Medicine
Study Director
clinicaltrials.gov ↗
David O Okonkwo, MD, PhD
University of Pittsburgh Medical Center
Study Director
clinicaltrials.gov ↗
Geoffrey T Manley, MD, PhD
University of California, San Francisco
Study Director
clinicaltrials.gov ↗
Joseph T Giacino, PhD
Harvard Medical School, Spaulding Rehabilitation Hospital
Study Director
clinicaltrials.gov ↗
Mike McCrea, PhD, ABPP
Medical College of Wisconsin
Principal Investigator
clinicaltrials.gov ↗
Murray B Stein, MD, MPH
University of California, San Diego
Study Director
clinicaltrials.gov ↗
Nancy R Temkin, PhD
University of Washington
Study Director
clinicaltrials.gov ↗
Pratik Mukherjee, MD, PhD
University of California, San Francisco
Study Director
clinicaltrials.gov ↗
Ramesh Grandhi, MD, MS
University of Utah
Principal Investigator
clinicaltrials.gov ↗
Ramon Diaz-Arrastia, MD, PhD
University of Pennsylvania
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jun 2021
Primary completion: 11 Nov 2022
Completion: 9 Apr 2030
Last update posted: 13 Apr 2025
Registered enrollment: 50
Registry id: NCT04602806

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.