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Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries

Study acronym: GUEST
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2025 (before its estimated December 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Oct 31, 2024 to Dec 15, 2025
    • Study completion date: Mar 30, 2025 to Mar 30, 2026
    • Start date changed from estimate of Apr 1, 2024 to Apr 19, 2024
    • Site details revised at 15 of 15 sites
  2. Primary completion date: Mar 31, 2024 to Oct 31, 2024
    • Start date: Oct 1, 2023 to Apr 1, 2024
    • Study completion date: Sep 30, 2024 to Mar 30, 2025
    v3
  3. Start date: Jun 30, 2023 to Oct 1, 2023
    • Primary completion date: Dec 31, 2023 to Mar 31, 2024
    • Study completion date: Jun 30, 2024 to Sep 30, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question : • Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury? Participants will do the exams planed in routine care and : * during the expected blood sampling an additional blood sample will be done, * seven days after the discharge a call will be done by the investigator.
Trial Details
NCT Number NCT05885529
Lead Sponsor Centre Hospitalier Princesse Grace
Collaborators: BioMérieux, Assistance Publique - Hôpitaux de Paris, University Hospital, Clermont-Ferrand, Hospices Civils de Lyon, Poitiers University Hospital, University Hospital, Angers, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier Universitaire de Nice, Nantes University Hospital, University Hospital, Montpellier, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, Fondation Hôpital Saint-Joseph, CHU de Tours
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov