Clinical trial NCT07021118: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emergency Departments
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: To assess the use of CT
timeFrame: September 2025 - August 2026
Secondary outcomes:
measure: Validate the most common scores
timeFrame: September 2026 - August 2027
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico di Milano Ospedale Maggiore
Study officials:
References: