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Head Injury TraumaBTER23NCT07339319

Treatment and Outcome of Patients With Mild Head Injury

An observational study of Head Injury Trauma, run by Azienda USL Reggio Emilia - IRCCS at 4 sites in Italy.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head Injury Trauma
How many people
4,500 participants
Where
4 sitesItaly
Study dates
1 Feb 2024to 31 Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy4 sites, 2 recruiting
  • Ospedale Maggiore di Bologna

    Bologna

    Active, not recruiting
  • Ospedale Sant'Orsola di Bologna

    Bologna

    Active, not recruiting
  • Ospedale di Ferrara

    Modena

    Michele Domenico Spampinato, MD, spmmhl@unife.it

    Not yet recruiting
  • AziendaUSL IRCCS Reggio Emilia

    Reggio Emilia

    Maria Giulia Galli, MD, mariagiulia.galli@ausl.re.it

    Recruiting

Other trials in Italy

About this study

Official title: Treatment and Outcome of Patients With Mild Head Injury: a Retrospective Multicentre Study in Emilia Romagna

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.

Read the detailed description

Head trauma is one of the main causes of visits to the emergency room and hospitalisation. Globally, it is estimated that there are approximately 50 million cases of head trauma each year. In the United Kingdom, it is the leading cause of death and disability in patients under the age of 40. In Italy, according to SINCH data, approximately 250 patients per 100,000 inhabitants are hospitalised for head trauma each year, with a mortality rate of 17 cases per 100,000 inhabitants per year.

Although numerous guidelines have been drawn up for the management of patients with head trauma, the lack of high-quality studies limits the effectiveness of the recommendations, leading to heterogeneous management from a diagnostic and therapeutic point of view.

The main objective of this multicentre, retrospective cohort study is to assess the incidence of complications in patients with head trauma who attend the emergency departments of the Emilia-Romagna Region. The complications considered include intracranial haemorrhages of any nature and neurological deficits that may require surgery and/or lead to death. The study also aims to compare and validate the prognostic accuracy of the Canadian CT Head Rule and the NEXUS Head CT Instrument in predicting post-traumatic complications, as found by brain computed tomography (CT) performed in the emergency department.

Furthermore, the study compares the different management strategies adopted and assesses the presence of additional predictive factors for the onset of meta-traumatic complications, not covered by the prognostic tools used.

To achieve these objectives, the study plans to include adult patients (aged ≥18 years) capable of providing informed consent, who have been assessed in the Emergency Department with a diagnosis of isolated head trauma and subsequently discharged home or transferred to the OBI (Short-Term Intensive Care), Emergency Medicine, or other hospital wards. Patients must have undergone a brain CT scan during their diagnostic-therapeutic pathway and arrived at the Emergency Department within 24 hours of the trauma. The study will record data relating to medical history (recent and remote), pharmacological management (with particular attention to the use of antiplatelet or anticoagulant therapies), criteria for calculating the Canadian CT Head Rule score (a validated tool that helps to reliably rule out the presence of intracranial lesions requiring neurosurgical intervention without resorting to a CT scan) and the NEXUS Head CT Instrument (a tool used to predict the need for brain CT in patients with closed head injury). Vital signs, instrumental and laboratory tests, medications administered (with dosage and method of administration), and any adverse events will also be recorded.

Keywords
isolated head injury, First Aid, brain CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (2)
  1. Prognostic Accuracy of the Canadian CT Head Rule and the NEXUS Head CT Instrument in Predicting Post-Traumatic Complications

    Evaluate the prognostic accuracy of the Canadian CT Head Rule and the NEXUS Head CT Instrument in predicting post-traumatic complications with Positive Predictive Value (PPV): Probability that patients identified as "high risk" will develop complications.

    Measured: 12 months

  2. Comparison of management strategies in the Emergency Department

    Compare the management strategies adopted in the Emergency Department for severe head trauma and identify predictive factors not considered by prognostic tools.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start1 Feb 2024
  3. Primary completion1 Apr 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07339319
Sponsor's protocol ID
1/2024/OSS/AUSLRE
Acronym
BTER23
Status last verified
Dec 2025
First submitted
5 Jan 2026
Last updated
16 Jan 2026
Results posted
No

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