Emergency DepartmentsNCT07021118
Mild TBI in the Emergency Department
An observational study of Emergency Departments, run by Mario Negri Institute for Pharmacological Research at 59 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Departments
- How many people
- 2,500 participants
- Where
- 59 sitesin 2 countries
- Study dates
- 21 Jan 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients arriving in the emergency department with mild TBI (Glasgow Coma Scale 13-15). Patients with trauma-associated loss of consciousness lasting more than 30 minutes and patients with post-traumatic amnesia lasting more than 24 hours.
Who may be able to join
- Adult patients arriving in the emergency department. Adult patients with mild TBI Adult patients with Glasgow Coma Scale 13-15.
Who cannot join
- 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.
Trial locations and contacts
59 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 2 countries
Italy58 sites, 29 recruiting
- Completed
AOU Ospedale Civile SS.Antonio e Biagio
Alessandria
- Not yet recruiting
Ospedali Riuniti di Anzio e Nettuno
Anzio, RM
Gabriele Valli, +39 06 9327 6591, gabriele.valli@aslroma6.it
- Recruiting
San Donato
Arezzo
Sara Montemerani, +39 0575 255000, sara.montemerani@gmail.com
- Completed
Ospedale S. Maria Annunziata
Bagno a Ripoli, FI
- Completed
Ospedale San Bassiano
Bassano del Grappa
- Completed
Ospedale Bentivoglio
Bentivoglio
- Not yet recruiting
Ospedale Papa Giovanni XXIII
Bergamo
Roberta Melgari, +39 035 267 4005, rmelgari@asst-pg23.it
- Completed
Ospedale degli Infermi
Biella
- Completed
Ospedale Maggiore "CA Pizzardi"
Bologna
- Not yet recruiting
Policlinico Sant'Orsola - Malpighi
Bologna
Roberto Emolo, +39 051 214 1111, roberto.emolo@aosp.bo.it
- Recruiting
Spedali Civili
Brescia
Cristiano Perani, +39 030 3995545, cristiano.perani@asst-spedalicivili.it
- Recruiting
Ospedale Unico della Versilia
Camaiore
Naria Park, +39 05846051, nariapark01@gmail.com
- Recruiting
Ospedale Cardarelli
Campobasso
Alessandro Salzmann, +39 0874 409311, alessandro.salzmann@gmail.com
- Recruiting
AOU Policlinico San Marco - PO San Marco
Catania
Paola Noto, +39 095 479 4111, p.noto@hotmail.it
- Completed
AOU Policlinico San Marco-PO Gaspare Rodolico
Catania
- Not yet recruiting
Ospedale Mellino Mellini
Chiari, BS
Nicoletta Romelli, +39 030 7102708, nicoletta.romelli@asst-franciacorta.it
- Active, not recruiting
Ospedale Civico
Chivasso, TO
- Active, not recruiting
Ospedale di Foligno
Foligno, PG
- Not yet recruiting
Ospedale San Martino
Genova
Luca Castellani, +369 010 5551, caste_luca@yahoo.it
- Recruiting
Ospedale Misericordia
Grosseto
Matteo Borselli, +39 0564 485111, matteo.borselli@uslsudest.toscana.it
- Recruiting
Ospedale Alessandro Manzoni
Lecco
Stefano Ghislanzoni, +39 0341253289, stefano.ghislanzoni@gmail.com
- Recruiting
Spedali Riuniti
Livorno
Emanuela Chella, +39 0586223111, chella.emanuela@gmail.com
- Not yet recruiting
Ospedale Maggiore
Lodi
Stefano Paglia, +39 0371 372346, Stefano.paglia@asst-lodi.it
- Not yet recruiting
Ospedale Fornaroli di Magenta
Magenta, MI
Stefano Sormani, +39 0297963209, stefano.sormani@asst-ovestmi.it
- Completed
Ospedale Carlo Poma
Mantua
- Completed
ASST Ca' Granda Niguarda
Milan
- Completed
ASST Fatebenefratelli Sacco, P.O. Luigi Sacco
Milan
- Active, not recruiting
IRCCS Ospedale San Raffaele
Milan
- Not yet recruiting
Ospedale Fatebenefratelli e Oftalmico
Milan
Lorenzo Porta, +39 02 6363 1, lorenzo.porta1992@gmail.com
- Completed
Policlinico di Milano Ospedale Maggiore
Milan
- Completed
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara
- Active, not recruiting
Ospedale Civile San Giacomo
Novi Ligure, AL
- Completed
AOU San Luigi Gonzaga
Orbassano
- Recruiting
AOU Padova
Padova
Renato Ippolito, +39 049 8212860, renato.ippolito@aopd.veneto.it
- Recruiting
Ospedale E. Agnelli Pinerolo
Pinerolo
Mimma Antonella Caserta, +39 0121 233677, mimmaantonella.caserta@aslto3.piemonte.it
- Active, not recruiting
AOU Pisana
Pisa
- Recruiting
Ospedale Santa Maria degli Angeli
Pordenone
Giuseppe Barbato, +39 0434 399293, giuseppe.barbato84@gmail.com
- Recruiting
Ospedale Santa Maria delle Grazie
Pozzuoli
Giovanni Porta, +39 081 8552885, dottorgiovanniporta@gmail.com
- Completed
Ospedale Santa Maria delle Croci
Ravenna
- Recruiting
Ospedale Infermi
Rimini, 47923
Marco Lunian, +39 0541 705111, marco.lunian@auslromagna.it
- Completed
Ospedale degli Infermi
Rivoli
- Active, not recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Francesco Franceschi, +39 06 8880.5560, francesco.franceschi@policlinicogemelli.it
- Recruiting
Istituto Clinico Humanitas
Rozzano
Antonio Voza, +39 0282241, antonio.voza@humanitas.it
- Completed
Ospedale Madonna del Soccorso
San Benedetto del Tronto
- Recruiting
Ospedale Città del Piave
San Donà di Piave, VE
Mirka Zucchetto, +39 0421 227501, mirka.zucchetto@aulss4.veneto.it
- Active, not recruiting
Ospedale Santa Maria dei Battuti
San Vito al Tagliamento, PN
- Active, not recruiting
Ospedale SS. Annunziata
Sassari
- Active, not recruiting
Ospedale San Matteo degli Infermi
Spoleto, PG
- Recruiting
Presidio Ospedaliero S'Antonio Abate
Tolmezzo, UD
Luca Norbis, +39 0433 488418, luca.norbis@asufc.sanita.fvg.it
- Recruiting
Humanitas Gradenigo
Torino
Carla Olivetti, +39 011 1910 1001, carla.olivetti@gradenigo.it
- Completed
Ospedale San Giovanni Bosco
Torino
- Recruiting
Ospedale Santa Chiara
Trento
Mjriam Sanò, +39 0461 903111, miriam.sano@asuit.tn.it
- Completed
Ospedale Ca' Foncello
Treviso
- Not yet recruiting
Ospedale di Circolo
Varese
Giulia Lupi, +39 0332 278 111, giulia.lupi@asst-settelaghi.it
- Active, not recruiting
P.O. Sant'Andrea
Vercelli
- Completed
Ospedale Michele e Pietro Ferrero
Verduno
- Recruiting
Ospedale Civile
Voghera
Pietro Pettenazza, +39 0383 6951, pietro_pettenazza@asst-pavia.it
About this study
Official title: The Use of Brain Computed Tomography in the Management of the Patient With Mild TBI in the Emergency Department
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.
Read the detailed description
Mild TBI is one of the most frequent causes of emergency department (ED) admission and is characterized by an increasing incidence. Brain computed tomography (CT) is a fundamental diagnostic tool to assess the presence and extent of any brain lesions and is commonly used in the ED for timely diagnosis. In particular, it allows to identify structural damage, such as hemorrhages, which could put the patient's life at risk if not treated promptly. However, the use of CT involves exposure to ionizing radiation, increases healthcare costs and can slow down the flow of patients in the ED. Considering that it is estimated that between 85% and 95% of patients with mild TBI do not have any brain lesions, a careful clinical evaluation is essential in indicating this investigation. These elements generate significant variability in the use of CT in mild TBI.
Several families of criteria and guidelines have been developed to support clinical decisions in this area, including the Canadian CT Head Rule, the Nexus II criteria, the New Orleans criteria and the National Institute for Health and Care Excellence (NICE) guidelines on head trauma. Although these criteria have been validated in multiple studies, their main objective is the identification of positive CT. This represents a limitation, since in many cases marginal brain injuries do not cause clinically relevant consequences or require specific interventions or treatments.
In this context, the present study aims to answer several research questions. First, the variability of CT use in Italian EDs will be analyzed, with the aim of identifying any discrepancies and the factors that determine them. The ultimate goal is to improve the quality of care for patients with mild head trauma. Second, the validity of the main tools proposed in the literature to support the clinical decision on the use of CT will be evaluated. Finally, the study aims to develop a new decision-making tool that can help ED physicians identify patients at risk of clinically relevant events in the short term, in order to facilitate a more accurate use of CT.
- Conditions
- Emergency Departments
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elegible population | Adult patients presenting to the emergency department for mild head trauma (Glasgow Coma Scale 13-15). Patients with trauma-related loss of consciousness lasting more than 30 minutes and patients with post-traumatic amnesia lasting more than 24 hours were excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the use of CT
The heterogeneity of CT use between centers will be assessed using the Pearson chi-square test. If significant heterogeneity in the case-mix of patients between EDs emerges, this crude analysis will be supported by a standardized analysis. Specifically, the Standardized Event Ratio (SER) will be calculated for each ED, i.e. the ratio between CT performed in a center and those expected based on the characteristics of patients arriving at that ED. The number of expected CBTs will be calculated using a logistic regression model, developed on all patients enrolled in the study.
Measured: September 2025 - August 2026
Secondary outcomes (2)
Validate the most common scores
The scores will be evaluated primarily on the basis of sensitivity with respect to the positivity of patients to CT. In fact, since these scores are developed with the aim of identifying patients for whom CT may not be performed safely, it is essential that the scores identify as positive all patients who present a lesion to CT, or that have a very high sensitivity. Secondary indicators of performance of the scores will be the specificity and the ROC curve with respect to the positivity of CT, and sensitivity, specificity and ROC curve with respect to the presence of a clinically relevant outcome at 30 days. Subgroup analyses are planned to evaluate the performance of the scores on patients taking antiplatelet and/or anticoagulant therapies or with coagulation disorders.
Measured: September 2026 - August 2027
Develop a new score to improve existing ones.
The development of a new score to guide the use of CT will be based on a multivariable logistic regression model. The outcome of interest will be the occurrence of clinically relevant events at 30 days from trauma in patients with positive CT. The variables collected in the study will be considered as candidate predictors and selected through a Least Absolute Shrinkage and Selection Operator (LASSO) model, which represents one of the most robust approaches to identify relevant predictors even in contexts where the number of candidate predictors is high compared to the sample size. The coefficients obtained from the model will be used to construct a composite score to estimate the probability of developing clinically relevant events at 30 days from mild head trauma.
Measured: January 2027 - August 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start21 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DepartmentsStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021118
- Sponsor's protocol ID
- TCL
- Status last verified
- Oct 2026
- First submitted
- 29 May 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Brain Computed Tomography in the Management of the Patient With Mild TBI in the Emergency Department
- ClinicalTrials.gov ID
- NCT07021118
- Acronym / sponsor ID
- TCL
- Conditions
- Emergency Departments
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mild TBI is one of the most frequent causes of emergency department (ED) admission and is characterized by an increasing incidence. Brain computed tomography (CT) is a fundamental diagnostic tool to assess the presence and extent of any brain lesions and is commonly used in the ED for timely diagnosis. In particular, it allows to identify structural damage, such as hemorrhages, which could put the patient's life at risk if not treated promptly. However, the use of CT involves exposure to ionizing radiation, increases healthcare costs and can slow down the flow of patients in the ED. Considering that it is estimated that between 85% and 95% of patients with mild TBI do not have any brain lesions, a careful clinical evaluation is essential in indicating this investigation. These elements generate significant variability in the use of CT in mild TBI.
Several families of criteria and guidelines have been developed to support clinical decisions in this area, including the Canadian CT Head Rule, the Nexus II criteria, the New Orleans criteria and the National Institute for Health and Care Excellence (NICE) guidelines on head trauma. Although these criteria have been validated in multiple studies, their main objective is the identification of positive CT. This represents a limitation, since in many cases marginal brain injuries do not cause clinically relevant consequences or require specific interventions or treatments.
In this context, the present study aims to answer several research questions. First, the variability of CT use in Italian EDs will be analyzed, with the aim of identifying any discrepancies and the factors that determine them. The ultimate goal is to improve the quality of care for patients with mild head trauma. Second, the validity of the main tools proposed in the literature to support the clinical decision on the use of CT will be evaluated. Finally, the study aims to develop a new decision-making tool that can help ED physicians identify patients at risk of clinically relevant events in the short term, in order to facilitate a more accurate use of CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elegible population | – | –Adult patients presenting to the emergency department for mild head trauma (Glasgow Coma Scale 13-15). Patients with trauma-related loss of consciousness lasting more than 30 minutes and patients with post-traumatic amnesia lasting more than 24 hours were excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients arriving in the emergency department with mild TBI (Glasgow Coma Scale 13-15). Patients with trauma-associated loss of consciousness lasting more than 30 minutes and patients with post-traumatic amnesia lasting more than 24 hours.
Key inclusion criteria (1 listed)
- Adult patients arriving in the emergency department. Adult patients with mild TBI Adult patients with Glasgow Coma Scale 13-15.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the use of CT
Time frame: September 2025 - August 2026
The heterogeneity of CT use between centers will be assessed using the Pearson chi-square test. If significant heterogeneity in the case-mix of patients between EDs emerges, this crude analysis will be supported by a standardized analysis. Specifically, the Standardized Event Ratio (SER) will be calculated for each ED, i.e. the ratio between CT performed in a center and those expected based on the characteristics of patients arriving at that ED. The number of expected CBTs will be calculated using a logistic regression model, developed on all patients enrolled in the study.
2 secondary outcomes
Validate the most common scores
Time frame: September 2026 - August 2027
Develop a new score to improve existing ones.
Time frame: January 2027 - August 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
59 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Departments, run by Mario Negri Institute for Pharmacological Research at 59 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Nattino (+39 0354535351, giovanni.nattino@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the use of CT (time frame: September 2025 - August 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.