Treatment and Outcome of Patients With Mild Head Injury
ConditionHead Injury Trauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda USL Reggio Emilia - IRCCS
About this trial
The study aims to assess the incidence of complications, such as intracranial haemorrhages and neurological deficits, in patients with head trauma treated in the emergency departments of the Emilia-Romagna Region and to compare the prognostic accuracy of the Canadian CT Head Rule and NEXUS Head CT Instrument in predicting post-traumatic complications. This is a retrospective multicentre cohort study that includes patients aged 18 years or older with isolated head trauma who underwent brain CT within 24 hours of the trauma. The data, sourced from hospital databases, will include medical history, prognostic scores, instrumental examinations, pharmacotherapy and adverse events. The primary objective is to determine the incidence of complications in patients who require surgery or who die, while the secondary objectives aim to compare the prognostic effectiveness of the two instruments in predicting complications. In addition, the study will examine the management strategies adopted and seek to identify any predictors of complications not included in current prognostic models. The results will contribute to improving the management of head trauma in emergency departments and optimising the use of available prognostic tools.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 18 years or older capable of self-determination
patients assessed in the emergency department with a final diagnosis of isolated head trauma, subsequently discharged home or transferred to the OBI, Emergency Medicine and/or possibly admitted to other wards, who have undergone at least one brain CT scan during their diagnostic-therapeutic pathway
GCS 13-15
presentation <24 hours after trauma
Disqualifiers
patients aged < 18 years
patients with multiple fractures outside the cranium
patients with head trauma who have not undergone a brain CT scan
GCS <13
Trial population
Patients aged ≥18 years, assessed in the Emergency Department with a diagnosis of isolated head trauma, who have undergone a brain CT scan within 24 hours of the trauma.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of complications following severe head trauma
To assess the incidence of complications, such as intracranial haemorrhages and neurological deficits, in patients with head trauma who require surgery and/or are at risk of death.
Time frame
12 monthsSecondary outcomes
1
Prognostic Accuracy of the Canadian CT Head Rule and the NEXUS Head CT Instrument in Predicting Post-Traumatic Complications
Evaluate the prognostic accuracy of the Canadian CT Head Rule and the NEXUS Head CT Instrument in predicting post-traumatic complications with Positive Predictive Value (PPV): Probability that patients identified as "high risk" will develop complications.
Time frame
12 months2
Comparison of management strategies in the Emergency Department
Compare the management strategies adopted in the Emergency Department for severe head trauma and identify predictive factors not considered by prognostic tools.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov