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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Drugs / interventions | radiation |
| Locations | 59 sites (Novi Ligure, AL and 58 other locations) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | January 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07021118 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
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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
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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
- Study coordinator: Giovanni Nattino
- Email: giovanni.nattino@marionegri.it
- Phone: +39 0354535351
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.