Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for Emergency Department Patients With Glasgow Coma Scale 15 Traumatic Brain Injury (PIONEER-Prognosis)

StatusNot Yet Recruiting
PhaseNot specified
Started

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Record History

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  1. Start date: Oct 1, 2026 to Oct 2026
  2. Eligibility criteria expanded, about 11 words Show 4 more changesShow less
    • Secondary endpoints revised (12)
    • Study description expanded, about 7 words
    • Study sites revised (5)
    • Study title expanded, about 11 words
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.
Trial Details
NCT Number NCT07858266
Lead Sponsor University of Michigan
Collaborators: Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov