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Clinical Trials in Italy / NCT07339319
Recruiting Observational

Treatment and Outcome of Patients With Mild Head Injury

NCT07339319 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda USL Reggio Emilia - IRCCS
Phase
Observational
Started
2024-02-01
Last updated
2026-01-16

Condition(s) studied

Head Injury Trauma

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Incidence of complications following severe head trauma — 12 months
    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.

Trial sites (4)

FacilityCityRegionStatus
Ospedale Maggiore di Bologna Bologna Italy Active Not Recruiting
Ospedale Sant'Orsola di Bologna Bologna Italy Active Not Recruiting
Ospedale di Ferrara Modena Italy Not Yet Recruiting
AziendaUSL IRCCS Reggio Emilia Reggio Emilia Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07339319 on ClinicalTrials.gov ↗ ← All trials in Italy