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NCT04602806 · ClinicalTrials.gov registry record

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

A clinical trial of Traumatic Brain Injury, sponsored by University of California, San Francisco.

Active
Registry status
50
Enrollment target
5
Study locations

NCT04602806: Active study of Traumatic Brain Injury, sponsored by University of California, San Francisco.

NCT04602806 is a study of Traumatic Brain Injury that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (82% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04602806, a study of Traumatic Brain Injury, is active but no longer recruiting, sponsored by University of California, San Francisco.

ACTIVE NOT RECRUITING
Registry status
50 participants
Enrollment target
5
Study locations

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.

Primary Outcome

Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NfL), Tau, Interleukin 6 (IL6), Interleukin (IL10), and Tumor Necrosis Factor (TNF) will be measured to validate their utility as early predictive and pharmacodynamic biomarkers for Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and Neuroinflammation. In addition, Ubiquitin C-terminal Hydrolase L1 (UCH-L1)/Glial fibrillary acidic protein (GFAP) markers will also be assayed for comparison.

Conditions Studied

Traumatic Brain Injury

Study Locations (5)

Pennsylvania

  • University of Pennsylvania/Penn Presbyterian Medical Center - Philadelphia
  • University of Pittsburgh Medical Center - Pittsburgh

California

  • University of California, San Francisco - San Francisco

Utah

  • University of Utah - Salt Lake City

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-06-01
Est. Completion 2030-04-09
University of California, San Francisco

1,713 total trials

What the registry record for NCT04602806 still lists

NCT04602806 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (82% lower).

The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 0 interventions.

NCT04602806 lists 5 locations in 4 states (Pennsylvania, California, Utah).

Frequently Asked Questions

What is clinical trial NCT04602806 about?

NCT04602806 is a clinical study titled "Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1". 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...

What is the current status of trial NCT04602806?

This trial is currently active not recruiting. The enrollment target is 50 participants. The study started on 2021-06-01. Estimated completion is 2030-04-09.

What conditions does trial NCT04602806 study?

This clinical trial studies the following conditions: Traumatic Brain Injury.

Who is sponsoring clinical trial NCT04602806?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04602806 being conducted?

This trial has 5 study locations across California, Pennsylvania, Utah, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Traumatic Brain Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04602806's enrollment target sits among peer trials

50 116th of 171 higher than 51 of 171 other Traumatic Brain Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04602806, the US trial registry maintained by the National Library of Medicine. NCT04602806 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.