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Mild TBI in the Emergency Department

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 31, 2026 → Jan 31, 2027
See other at-risk trials from Mario Negri Institute for Pharmacological Research

Record History

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  1. Primary completion pushed from Aug 31, 2026 to Jan 31, 2027
    • Trial sites expanded: 24 → 59 locations
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2025 to Jan 21, 2026
    • Study sites: 1 to 24
    v3
  3. Secondary endpoints: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Mild TBI is one of the main causes of admission to the Emergency Department (ED). Brain computed tomography (CT) is one of the most widely used diagnostic tools to assess the presence of intracranial lesions. However, in Western countries, 85-95% of CT scans performed in the ED for mild TBI are negative. It is therefore conceivable that a significant number of CTs could be avoided by a more careful use of this exam. On the other hand, excessive use of CT exposes patients to unnecessary radiation, increases healthcare costs and slows down the management of patients in the ED. This study aims to analyze the variability in the use of CT in mild TBI in Italian EDs, validate the scores designed to help the physician decide when to use it and develop a model that predicts the medium-term outcome of patients with mild head trauma.
Trial Details
NCT Number NCT07021118
Lead Sponsor Mario Negri Institute for Pharmacological Research
Conditions
(from sponsor)		 Emergency Departments
Related terms Emergencies
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov