Actively Recruiting

Age: 18Years +
All Genders
NCT07339319

Treatment and Outcome of Patients With Mild Head Injury

Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2026-01-16

4500

Participants Needed

4

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Treatment and Outcome of Patients With Mild Head Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older capable of self-determination
  • Patients assessed in the emergency department with a final diagnosis of isolated head trauma
  • Patients subsequently discharged home or transferred to the OBI, Emergency Medicine, or other hospital wards
  • Patients who have undergone at least one brain CT scan during their diagnostic-therapeutic pathway
  • Glasgow Coma Scale (GCS) score between 13 and 15
  • Presentation to emergency department less than 24 hours after trauma
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Patients with multiple fractures outside the cranium
  • Patients with head trauma who have not undergone a brain CT scan
  • Glasgow Coma Scale (GCS) score less than 13

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Ospedale Maggiore di Bologna

Bologna, Italy

Active, Not Recruiting

2

Ospedale Sant'Orsola di Bologna

Bologna, Italy

Active, Not Recruiting

3

Ospedale di Ferrara

Modena, Italy

Not Yet Recruiting

4

AziendaUSL IRCCS Reggio Emilia

Reggio Emilia, Italy

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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