Mild TBI in the Emergency Department
ConditionEmergency Departments
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,500 Participants
are grouped into 1 trial groupGroup A: Elegible population
Trial outcomes
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.
Time frame
September 2025 - August 2026Secondary outcomes
1
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.
Time frame
September 2026 - August 20272
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.
Time frame
January 2027 - August 2027Sponsors and contacts
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Source ClinicalTrials.gov