Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07041086

Prehospital ECPR in Moravia Silesia Region

Cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) in specific cases could be improved by Extracorporeal membrane oxygenation (ECMO; ECPR). ECPR could be introduced in hospital after retrieval of an OHCA patient and also faster by implantation on scene. The aim is to verify the effectiveness of ECPR on scene in the Moravian-Silesian region.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Medical Services, Moravian-Silesian Region, Ostrava, Moravian-Silesian Region, Czechia

Loading trial locations.

About this study

Patients undergoing cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) have a poor prognosis and a good long-term neurological outcome is achieved in about 10% of them. Extracorporeal membrane oxygenation (ECMO) can lead to an improvement in neurological outcome of up to 30% in a selected group of these critically ill patients. CPR for OHCA using ECMO in the hospital after patient admission (ECPR) is very demanding and depends on the best collaboration of pre-hospital care components with the hospital management. As good as the coordination of the different phases of care and transport is, patients often arrive to the hospital relatively late (over 60 minutes), and although the process of diagnosis and indication and ECMO implantation itself is rapid (approximately 15 minutes), the overall time from collapse to ECMO initiation is relatively long (over 60 minutes). It is this time, i.e. the duration of low organ perfusion during CPR, that may be the key parameter in determining the overall neurological outcome of treatment and prognosis of patients. Shortening this interval by having the ECMO team go to well-defined OHCA cases simultaneously with the ambulance car of the Emergency Department and connecting the patient to ECMO already in the field may lead to an improvement in the neurological outcome of the treatment of OHCA patients. In many locations abroad, this model is already used, and patients are connected to ECMO already in the field. Whether the model of field ECPR can be used in the Moravian-Silesian Region depends on a number of variables. These include the logic of information acquisition and selection of suitable patients, the logic of transporting the team and material to the scene, and the logic of connection with the provision of a safe and suitable environment for the ECMO implantation itself. The goal of this study is to validate the feasibility of the method on a simulated ECPR OHCA and further implant the mobile ECPR project in the Moravian-Silesian region.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Observed collapse and presumption of cardiac cause of cardiac arrest
  • Estimated age up to 70 years
  • Baseline rhythm of ventricular fibrillation or pulseless electrical activity (PEA)
  • Basic bystander cardiopulmonary resuscitation (CPR), "bystander CPR", telephone assisted CPR (TANR)

Exclusion criteria

  • Children or adults with estimated weight below 40 kg
  • Known major comorbidities of the patient suggesting low rehabilitation potential (e.g. chronic obstructive pulmonary disease (COPD) IV, malignancy in tertiary phase)

Treatment and study plan

ExtraCorporeal Membrane Oxygenation (ECMO)

Procedure

In extracorporeal membrane oxygenation (ECMO), blood is pumped outside of the body to a heart-lung machine. The machine removes carbon dioxide and sends oxygen-rich blood back to the body. Blood flows from the right side of the heart to the heart-lung machine. It's then rewarmed and sent back to the body.

Primary outcomes

  1. Time from cardiac arrest (collapse) to implantation of ECMO

    Time frame: up to 60 minutes

    The time from cardiac arrest (collapse) to implantation of ECMO will be recorded and assessed

  2. Hospital mortality

    Time frame: up to 3 weeks

    Hospital mortality will be assessed for the period of 3 weeks

  3. Cerebral Performance Category (CPC) score

    Time frame: 30 days

    Cerebral Performance Category (CPC) score will be observed 30 days after cardiac arrest

  4. Neurological outcome (CPC score)

    Time frame: 6 months

    Neurological outcome will be assessed using the Cerebral Performance Category Scale (CPC) 6 months after cardiac arrest.

  5. Neurological outcome (SF-36)

    Time frame: 6 months

    Neurological outcome will be assessed using the Short Form 36 Health Subject Questionnaire (SF-36) 6 months after cardiac arrest.

  6. Neurological outcome (EQ-5D)

    Time frame: 6 months

    Neurological outcome will be assessed using the European Quality of Life Questionnaire (EQ-5D) 6 months after cardiac arrest.

Study contacts

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

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Emergency Medical Services, Moravian-Silesian Region

Registry information

Official study title

Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.

Acronym: 01-Pain

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 27, 2025
Registry last updated
Jan 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.

Published trials that share one or more normalized conditions with this study.