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NCT Number: NCT07589504

The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna Region

Out-of-hospital cardiac arrest (OHCA) is a life-threatening emergency and one of the leading causes of death worldwide. Survival depends critically on how quickly help arrives and whether cardiopulmonary resuscitation (CPR) and defibrillation are started early. In recent years, many regions in Europe and Italy, including Emilia-Romagna, have introduced systems that alert nearby volunteers, called First Responders (FRs), through smartphone applications (such as DAE RespondER). These individuals can reach the patient before emergency medical services (EMS) and begin life-saving actions.

The FIRSST-RER study aims to evaluate whether the intervention of First Responders improves survival in patients with out-of-hospital cardiac arrest in Emilia-Romagna.

This is a multicentre observational study involving approximately 5,000 adult patients who experienced cardiac arrest between 2018 and 2025 and were treated by the regional emergency system.

The study compares two groups of patients:

those who received help from at least one First Responder activated via the app those who did not receive First Responder intervention

The main objective is to determine whether First Responders increase survival at 30 days after cardiac arrest.

Additional objectives include evaluating:

survival at 6 months and 1 year neurological outcomes (brain function recovery)

Data for this study are collected from existing healthcare and emergency system databases, including EMS dispatch records, national health data systems, and the DAE RespondER platform.

For patients who survive, follow-up information may be collected through medical records or telephone contact.

Importantly, this study does not involve any experimental treatments or changes in patient care. It is based entirely on data already collected during routine emergency care, and therefore does not pose additional risks to patients.

All data are handled securely and in compliance with privacy regulations. Personal identifiers are replaced with coded information (pseudonymisation), and only authorised researchers can access the data. Patients who are alive may be contacted to provide consent and additional follow-up information; participation is voluntary, and consent can be withdrawn at any time.

The results of this study will provide important evidence on the effectiveness of citizen responder systems and may help guide future improvements in emergency response organisation, public health strategies, and training programmes. Ultimately, the goal is to increase survival and improve outcomes for people experiencing cardiac arrest in the community.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Carlo Alberto Pizzardi Major Hospital

Bologna, Emilia-Romagna, Italy

Location contact

Lorenzo Gamberini, Medical Doctor

CONTACT

[email protected]

+390516378215

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Confirmed out-of-hospital cardiac arrest (OHCA)
  • Emergency medical services activation with Advanced Life Support dispatch (Code Red Advanced Blue)
  • OHCA confirmed by return code 2-3-4 and/or NSIS codes (C0208 or C0205)
  • Event occurring between 1 January 2018 and 31 December 2025
  • Activation of the regional emergency medical system (Emilia-Romagna 118 system)

Exclusion criteria

  • Age <18 years
  • Cardiac arrest not confirmed after EMS assessment
  • Cases with return code <2 (misclassified as cardiac arrest)

Treatment and study plan

Primary outcomes

  1. Survival at 30 Days After Out-of-Hospital Cardiac Arrest

    Time frame: 30 days after the index event

    All-cause survival at 30 days after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.

Secondary outcomes

  1. Survival at 6 Months After Out-of-Hospital Cardiac Arrest

    Time frame: 6 months after the index event

    All-cause survival at 6 months after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.

  2. Survival at 1 Year After Out-of-Hospital Cardiac Arrest

    Time frame: 1 year after the index event

    All-cause survival at 1 year after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.

  3. Favourable Neurological Outcome at Follow-Up

    Time frame: Up to 1 year after the index event

    Neurological outcome assessed at the longest available follow-up using the Cerebral Performance Category (CPC) scale. Favourable outcome is defined as CPC 1-2, and unfavourable outcome as CPC 3-5.

  4. Survival at 30 Days According to First Responder Training Level

    Time frame: 30 days after the index event

    Comparison of 30-day survival between patients receiving intervention from trained First Responders (BLS/ALS certified) and those receiving intervention from untrained First Responders.

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Gamberini, Medical Doctor

CONTACT

[email protected]

+390516478215

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Official study title

FIRSST-RER Study: The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna

Acronym: FIRSST-RER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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