Treatment and Outcome of Patients With Mild Head Injury

Recruiting now

Conditions studied: Head Injury Trauma

In brief

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.

Key facts

Study ID

NCT07339319

Run by

Azienda USL Reggio Emilia - IRCCS

People needed

4500

Starts

2024-02-01

Expected to finish

2026-12-31

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AziendaUSL IRCCS Reggio Emilia — Reggio Emilia, Italy (enrolling)
• Ospedale Maggiore di Bologna — Bologna, Italy
• Ospedale Sant'Orsola di Bologna — Bologna, Italy
• Ospedale di Ferrara — Modena, Italy

Full record on ClinicalTrials.gov

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