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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04602806
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Oct 26, 2020
Start date
Jun 1, 2021
Status verified
Sep 2026
Primary completion
Feb 28, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Moderate to Severe TBI Subjects
    Adult patients (age 18-65y inclusive) presenting to the Emergency Department (ED) with a history of acute TBI as per American Congress of Rehabilitation Medicine (ACRM) Criteria (i.e., patient has sustained a traumatically-induced physiological disruption of brain function).

Primary Outcome Measure

Blood Specimen for Analysis of Biomarkers [ Time Frame: < 6 hours from the time of TBI ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110-
University of Pennsylvania/Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
University of UtahSalt Lake CityUtah84132-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAUniversity of Pennsylvania/Penn Presbyterian Medical Center· Philadelphia, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PAUniversity of Utah· Salt Lake City, UTMedical College of Wisconsin· Milwaukee, WI

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