NCT07339319 Treatment and Outcome of Patients With Mild Head Injury
| NCT ID | NCT07339319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda USL Reggio Emilia - IRCCS |
| Condition | Head Injury Trauma |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,500 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,500 participants in total. It began in 2024-02-01 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07339319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head Injury Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07339319 currently recruiting?
Yes, NCT07339319 is actively recruiting participants. Visit ClinicalTrials.gov or contact Azienda USL Reggio Emilia - IRCCS to inquire about joining.
Where is the NCT07339319 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy, Modena, Italy, Reggio Emilia, Italy.
Who is sponsoring the NCT07339319 clinical trial?
NCT07339319 is sponsored by Azienda USL Reggio Emilia - IRCCS. The trial plans to enroll 4,500 participants.