Treatment and outcomes after mild head injury
Treatment and Outcome of Patients With Mild Head Injury: a Retrospective Multicentre Study in Emilia Romagna
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 |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 4 sites (Bologna and 3 other locations) |
| Trial ID | NCT07339319 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna and 3 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.