Treatment and outcomes after mild head injury
Official title: Treatment and Outcome of Patients With Mild Head Injury: a Retrospective Multicentre Study in Emilia Romagna
Run by Azienda USL Reggio Emilia - IRCCS · NCT07339319 · Data updated 2026-11-12
Researchers are looking at past emergency department records to see how often adults with mild head injury develop serious complications and whether the Canadian CT Head Rule or the NEXUS Head CT better predicts who will need surgery or die.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4500 (estimated) |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 4 sites (Bologna and 3 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | April 1, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07339319 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with isolated head trauma, a GCS of 13–15, who presented within 24 hours and underwent at least one brain CT during their emergency department care in participating Emilia-Romagna hospitals.
✕Probably not a fit
People under 18, those with multi-system trauma or no brain CT, patients with GCS <13, or patients treated outside the participating hospitals are not represented and likely would not benefit from these specific findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicentre retrospective cohort using hospital records from emergency departments in the Emilia-Romagna region. It includes adults (≥18 years) with isolated head trauma, GCS 13–15, who had a brain CT within 24 hours of injury. Collected data will include medical history, prognostic scores, imaging, treatments and adverse events, with the primary outcome being complications that require surgery or cause death. Secondary analyses will compare the prognostic accuracy of the Canadian CT Head Rule versus the NEXUS Head CT instrument and describe management strategies and additional predictive factors.
Why it matters
Potential benefit: If successful, the results could help clinicians better predict which adults with mild head injury are at risk of serious complications, leading to more targeted CT use and clearer, safer management pathways.
How similar studies have gone: Prior prospective and retrospective work has validated the Canadian CT Head Rule and NEXUS Head CT for identifying clinically important brain injury, but direct multicentre regional comparisons like this are relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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AziendaUSL IRCCS Reggio Emilia
Reggio Emilia, Italy Recruiting -
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.