๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-09

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1 (NCT04602806)

TRACK-TBI Precision Medicine Phase 2-Option I

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: University of California, San Francisco

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of California, San Francisco โ€” San Francisco, California

Age range: 18 Years to 65 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (5 Sites)

  • University of California, San Francisco โ€” San Francisco, California
  • University of Pennsylvania/Penn Presbyterian Medical Center โ€” Philadelphia, Pennsylvania
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • University of Utah โ€” Salt Lake City, Utah
  • Medical College of Wisconsin โ€” Milwaukee, Wisconsin

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—