Treatment and Outcome of Patients With Mild Head Injury

NCT07339319 | Recruiting

• 1 other identifier: 1/2024/OSS/AUSLRE
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Head Injury Trauma

Keywords

isolated head injury; First Aid; brain CT scan

Outcome Measures

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.

  12 months

Secondary Outcomes (2)

• Prognostic Accuracy of the Canadian CT Head Rule and the NEXUS Head CT Instrument in Predicting Post-Traumatic Complications

  12 months

• Comparison of management strategies in the Emergency Department

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (4)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 14, 2026
• Study Start: February 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

IT (4)