Cardiac Arrest, Out-Of-Hospital01-PainNCT07041086
Prehospital ECPR in Moravia Silesia Region
An observational study of Cardiac Arrest, Out-Of-Hospital, run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- Extracorporeal membrane oxygenation (ECMO)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- 17 Jun 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after out-of-hospital cardiac arrest
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
Emergency Medical Services, Moravian-Silesian Region
Ostrava, Moravian-Silesian Region, 700 30
David Holeš, MD, PhD, 00420597011401, david.holes@zzsmsk.cz
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Filip Burša, MD, PhD, EDEC
About this study
Official title: Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.
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.
Read the detailed description
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.
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- Extracorporeal membrane oxygenation (ECMO)
- Keywords
- ECMO, Cardiac arrest, Cardiopulmonary resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal membrane oxygenation (ECMO)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Out-of-hospital cardiac arrest on ECMO | Patients with out-of-hospital cardiac arrest indicated for ECMO Receives: Procedure: Extracorporeal membrane oxygenation (ECMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from cardiac arrest (collapse) to implantation of ECMO
The time from cardiac arrest (collapse) to implantation of ECMO will be recorded and assessed
Measured: up to 60 minutes
Hospital mortality
Hospital mortality will be assessed for the period of 3 weeks
Measured: up to 3 weeks
Cerebral Performance Category (CPC) score
Cerebral Performance Category (CPC) score will be observed 30 days after cardiac arrest
Measured: 30 days
Neurological outcome (CPC score)
Neurological outcome will be assessed using the Cerebral Performance Category Scale (CPC) 6 months after cardiac arrest.
Measured: 6 months
Neurological outcome (SF-36)
Neurological outcome will be assessed using the Short Form 36 Health Subject Questionnaire (SF-36) 6 months after cardiac arrest.
Measured: 6 months
Neurological outcome (EQ-5D)
Neurological outcome will be assessed using the European Quality of Life Questionnaire (EQ-5D) 6 months after cardiac arrest.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start17 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Medical Services, Moravian-Silesian Region
- Responsible party
- Sponsor
- Investigators
- Filip Burša, MD, PhD, EDEC, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041086
- Sponsor's protocol ID
- FNO-KARIM-01-Pain
- Acronym
- 01-Pain
- Status last verified
- Jan 2026
- First submitted
- 12 Jun 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.
- ClinicalTrials.gov ID
- NCT07041086
- Acronym / sponsor ID
- 01-Pain / FNO-KARIM-01-Pain
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Keywords
- ECMO, Cardiac arrest, Cardiopulmonary resuscitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Emergency Medical Services, Moravian-Silesian Region
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest on ECMO | – | Procedure: Extracorporeal membrane oxygenation (ECMO)Patients with out-of-hospital cardiac arrest indicated for ECMO |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after out-of-hospital cardiac arrest
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal membrane oxygenation (ECMO)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. | Procedure or surgery | Out-of-hospital cardiac arrest on ECMO |
Primary outcome
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
Hospital mortality
Time frame: up to 3 weeks
Hospital mortality will be assessed for the period of 3 weeks
Cerebral Performance Category (CPC) score
Time frame: 30 days
Cerebral Performance Category (CPC) score will be observed 30 days after cardiac arrest
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filip Burša, MD, PhD, EDEC principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Out-Of-Hospital, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from cardiac arrest (collapse) to implantation of ECMO (time frame: up to 60 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.