Clinical trial Recruiting at 20 sites Observational Ages 18 and up

Mild TBI in the Emergency Department

Official title: The Use of Brain Computed Tomography in the Management of the Patient With Mild TBI in the Emergency Department

Run by Mario Negri Institute for Pharmacological Research · NCT07021118 · Data updated 2026-11-12

This study tests how often CT scans are needed for adults with mild brain injury in emergency departments and aims to predict short-term outcomes using existing decision rules and new models.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2500 (estimated)
SponsorMario Negri Institute for Pharmacological Research
Academic / other
Drugs / interventionsradiation
Locations59 sites (Novi Ligure, AL and 58 other locations)
StatusRecruiting
StartedJanuary 21, 2026
Main results expectedJanuary 31, 2027
Study endsAugust 31, 2027
Registry record updatedOctober 7, 2026
Trial IDNCT07021118 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18 or older) with mild traumatic brain injury presenting to participating EDs, and a Glasgow Coma Scale of 13-15.

Probably not a fit

Patients with clear indications for CT or those who do not fit the study’s criteria may not gain direct benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes CT use for adults with mild traumatic brain injury presenting to Italian emergency departments. It evaluates existing decision rules (e.g., Canadian CT Head Rule, Nexus II, New Orleans criteria, NICE guidelines) and aims to validate these tools while developing a model to predict medium-term outcomes. The project seeks to understand practice variability, reduce unnecessary radiation exposure, and inform more efficient patient management in the ED. It will enroll adult ED patients with mild TBI (Glasgow Coma Scale 13-15), excluding those under 18 or with prolonged loss of consciousness or amnesia. Lead coordination is by the Mario Negri Institute, with sites in Novi Ligure, Chiari, and Bagno a Ripoli.

Why it matters

Potential benefit: If successful, the study could help doctors better decide when CT scans are truly needed, reducing radiation exposure and speeding patient care.

How similar studies have gone: Previous work has validated clinical decision rules for CT use in mild TBI, but this study adds validation in Italian ED settings and seeks to develop a predictive model for medium-term outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Adult patients arriving in the emergency department. Adult patients with mild TBI Adult patients with Glasgow Coma Scale 13-15.

Exclusion Criteria:

All patients under 18 years. Patients with trauma-associated loss of consciousness lasting more than 30 minutes.

Patients with post-traumatic amnesia lasting more than 24 hours.

Where it's running

  • Presidio Ospedaliero S'Antonio Abate
    Tolmezzo, Ud, Italy
    Recruiting
  • Ospedale Città del Piave
    San Donà di Piave, Ve, Italy
    Recruiting
  • San Donato
    Arezzo, Italy
    Recruiting
  • Spedali Civili
    Brescia, Italy
    Recruiting
  • Ospedale Unico della Versilia
    Camaiore, Italy
    Recruiting
  • Ospedale Cardarelli
    Campobasso, Italy
    Recruiting
Show 44 more locations
  • AOU Policlinico San Marco - PO San Marco
    Catania, Italy
    Recruiting
  • Ospedale Misericordia
    Grosseto, Italy
    Recruiting
  • Ospedale Alessandro Manzoni
    Lecco, Italy
    Recruiting
  • Spedali Riuniti
    Livorno, Italy
    Recruiting
  • AOU Padova
    Padova, Italy
    Recruiting
  • Ospedale E. Agnelli Pinerolo
    Pinerolo, Italy
    Recruiting
  • Ospedale Santa Maria degli Angeli
    Pordenone, Italy
    Recruiting
  • Ospedale Santa Maria delle Grazie
    Pozzuoli, Italy
    Recruiting
  • Ospedale Infermi
    Rimini, Italy
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, Italy
    Recruiting
  • Istituto Clinico Humanitas
    Rozzano, Italy
    Recruiting
  • Humanitas Gradenigo
    Torino, Italy
    Recruiting
  • Ospedale Santa Chiara
    Trento, Italy
    Recruiting
  • Ospedale Civile
    Voghera, Italy
    Recruiting
  • Ospedale Civile San Giacomo
    Novi Ligure, Al, Italy
    Active not recruiting
  • Ospedale Mellino Mellini
    Chiari, Bs, Italy
    Not yet recruiting
  • Ospedale S. Maria Annunziata
    Bagno a Ripoli, Fi, Italy
    Completed
  • Ospedale Fornaroli di Magenta
    Magenta, Mi, Italy
    Not yet recruiting
  • Ospedale di Foligno
    Foligno, Pg, Italy
    Active not recruiting
  • Ospedale San Matteo degli Infermi
    Spoleto, Pg, Italy
    Active not recruiting
  • Ospedale Santa Maria dei Battuti
    San Vito al Tagliamento, Pn, Italy
    Active not recruiting
  • Ospedali Riuniti di Anzio e Nettuno
    Anzio, Rm, Italy
    Not yet recruiting
  • Ospedale Civico
    Chivasso, To, Italy
    Active not recruiting
  • AOU Ospedale Civile SS.Antonio e Biagio
    Alessandria, Italy
    Completed
  • Ospedale San Bassiano
    Bassano del Grappa, Italy
    Completed
  • Ospedale Bentivoglio
    Bentivoglio, Italy
    Completed
  • Ospedale Papa Giovanni XXIII
    Bergamo, Italy
    Not yet recruiting
  • Ospedale degli Infermi
    Biella, Italy
    Completed
  • Ospedale Maggiore "CA Pizzardi"
    Bologna, Italy
    Completed
  • Policlinico Sant'Orsola - Malpighi
    Bologna, Italy
    Not yet recruiting
  • AOU Policlinico San Marco-PO Gaspare Rodolico
    Catania, Italy
    Completed
  • Ospedale San Martino
    Genova, Italy
    Not yet recruiting
  • Ospedale Maggiore
    Lodi, Italy
    Not yet recruiting
  • Ospedale Carlo Poma
    Mantua, Italy
    Completed
  • ASST Ca' Granda Niguarda
    Milan, Italy
    Completed
  • ASST Fatebenefratelli Sacco, P.O. Luigi Sacco
    Milan, Italy
    Completed
  • IRCCS Ospedale San Raffaele
    Milan, Italy
    Active not recruiting
  • Ospedale Fatebenefratelli e Oftalmico
    Milan, Italy
    Not yet recruiting
  • Policlinico di Milano Ospedale Maggiore
    Milan, Italy
    Completed
  • Azienda Ospedaliero-Universitaria Maggiore della Carità
    Novara, Italy
    Completed
  • AOU San Luigi Gonzaga
    Orbassano, Italy
    Completed
  • AOU Pisana
    Pisa, Italy
    Active not recruiting
  • Ospedale Santa Maria delle Croci
    Ravenna, Italy
    Completed
  • Ospedale degli Infermi
    Rivoli, Italy
    Completed

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.