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NCT Number: NCT07155772

Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province.

This is a single Center interventional study, assessing the feasibility of a complex treatment strategy where an in-hospital standard care process is applied in an out-of-hospital cardiac arrest.

The objective of this study is to investigate the feasibility of a prehospital eCPR program in the context of the Pavia province in order to reduce the time from cardiac arrest to organ reperfusion with thefarthest aim of improving survival and good neurologic outcomes of patient victims of refractory cardiac arrest.

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Key information

Conditions

Refractory Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Alessandra Palo, MD

CONTACT

[email protected]

+39 0382 50 3711

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • out-of-hospital cardiac arrest occurred in Pavia province
  • the age of the patient is between 18 and 70
  • witnessed cardiac arrest
  • CPR started within 5 minutes of the patient's collapse or presence of gasping at the arrival of the ACLS team
  • eCPR team arrived within 60 minutes of the patient's collapse
  • etCO2 ≥ 10 mmHg
  • mechanical chest compression is ongoing
  • refractory cardiac arrest after at least 15 minutes of ACLS

Exclusion criteria

  • Modified Rankin Scale (mRS) ≥ 3
  • Advanced COPD or other advanced pulmonary illness
  • End-stage or metastatic neoplasm

Treatment and study plan

Extracorporeal cardiopulmonary resuscitation (ECPR)

Procedure

The intervention of this study consists of moving the current eCPR program out of the hospital to reduce the time from collapse to ECMO flow (low-flow time).

Primary outcomes

  1. number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria

    Time frame: up to 12 months

    Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.

Secondary outcomes

  1. Cause of cannulation failure

    Time frame: up to 12 months

  2. Proportion of cannulation feasibility according to the implant site

    Time frame: up to 12 months

  3. Evaluation of eCPR Team Performance

    Time frame: up to 12 months

    Evaluation of eCPR Team Performance to better design a definitive institutional eCPR program

Study contacts

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

Alessandra Palo, MD

CONTACT

[email protected]

+39 0382 50 3711

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province. An Interventional Study on Complex Treatment Strategy

Acronym: eCPR on Site

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

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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