Mild TBI in the Emergency Department

NCT07021118 | Recruiting

• 1 other identifier: TCL
• Study Type: observational
• Target: 2,500
• Locations: 2 countries
• Sites: 24

Brief 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. 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.

Conditions

Emergency Departments

Outcome Measures

Primary Outcomes (1)

• 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.

  September 2025 - August 2026

Secondary Outcomes (2)

• Validate the most common scores

  September 2026 - August 2027

• Develop a new score to improve existing ones.

  January 2027 - August 2027

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (24)

AOU Ospedale Civile SS.Antonio e Biagio

Alessandria, Italy

COMPLETED

Ospedale San Bassiano

Bassano del Grappa, Italy

RECRUITING

Ospedale Bentivoglio

Bentivoglio, Italy

COMPLETED

Ospedale degli Infermi

Biella, Italy

COMPLETED

Ospedale Maggiore "CA Pizzardi"

Bologna, Italy

COMPLETED

Spedali Civili

Brescia, Italy

RECRUITING

Ospedale Unico della Versilia

Camaiore, Italy

RECRUITING

AOU Policlinico San Marco-PO Gaspare Rodolico

Catania, Italy

RECRUITING

Ospedale Carlo Poma

Mantua, Italy

RECRUITING

ASST Ca' Granda Niguarda

Milan, Italy

COMPLETED

ASST Fatebenefratelli Sacco, P.O. Luigi Sacco

Milan, Italy

RECRUITING

Policlinico di Milano Ospedale Maggiore

Milan, Italy

COMPLETED

AOU San Luigi Gonzaga

Orbassano, Italy

COMPLETED

Ospedale E. Agnelli Pinerolo

Pinerolo, Italy

RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, Italy

COMPLETED

Ospedale degli Infermi

Rivoli, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Italy

RECRUITING

Ospedale Madonna del Soccorso

San Benedetto del Tronto, Italy

RECRUITING

Humanitas Gradenigo

Torino, Italy

RECRUITING

Ospedale San Giovanni Bosco

Torino, Italy

COMPLETED

Ospedale Ca' Foncello

Treviso, Italy

RECRUITING

Ospedale Michele e Pietro Ferrero

Verduno, Italy

COMPLETED

Ospedale Civile

Voghera, Italy

RECRUITING

Ente Ospedaliero Cantonale

Lugano, Switzerland

COMPLETED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giovanni Nattino

CONTACT

+39 0354535351; giovanni.nattino@marionegri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 13, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

IT (23); CH (1)