Cardiac Arrest With Successful ResuscitationNCT07009652
Optimization of Transport and Use of a Mobile ECMO Team in Patients With Sudden Cardiac Arrest in the Moravian-Silesian Region
An observational study of Cardiac Arrest With Successful Resuscitation and Cardiac Arrest, Cause Unspecified, run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
This study evaluates the feasibility of implementing a mobile extracorporeal membrane oxygenation (ECMO) team and optimizing patient transport logistics. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation, Cardiac Arrest, Cause Unspecified
- What is being tested?
- Extracorporeal cardiopulmonary resuscitation (ECPR)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 May 2025to 1 May 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients indicated for ECPR after out-of-hospital cardiac arrest, for whom transport of the patient to an ECMO centre or deployment of an ECMO team is logistically manage-able.
Who may be able to join
- out-of-hospital cardiac arrest
- indication for ECPR
Who cannot join
- death at the scene of the accident
- withdrawal of the informed consent
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 Medial Services, Moravian-Silesian Region
Ostrava, Moravian-Silesian Region, 70030
Filip Burša, MD, Ph.D., EDEC, 0042059737 ext. 2713, filip.bursa@fno.cz
Filip Burša, MD, Ph.D., EDEC
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Nela Walachová, Mgr.
About this study
Official title: Proposal for the Organisation of the Procedure for Extracorporeal Cardiopulmonary Resuscitation of Patients With Sudden Cardiac Arrest in the Pre-hospital Environment of the Moravian-Silesian Region
This study evaluates the feasibility of implementing a mobile extracorporeal membrane oxygenation (ECMO) team and optimizing patient transport logistics.
Read the detailed description
The aim of the study is to improve neurological outcomes in out-of-hospital cardiac arrest (OHCA) cases in the Moravian-Silesian Region. By analysing regional epidemiological and demographic data, the project aims to identify key factors for reducing the time from collapse to the initiation of ECMO and to support the development of effective protocols for extracorporeal cardiopulmonary resuscitation (ECPR).
- Being tested
- Extracorporeal cardiopulmonary resuscitation (ECPR)
- Keywords
- cardiac arrest, extracorporeal membrane oxygenation, out-of-hospital cardiac arrest, extracorporeal cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal cardiopulmonary resuscitation (ECPR)Procedure or surgery
Extracorporeal cardiopulmonary resuscitation (commonly known as ECPR) is a method of cardiopulmonary resuscitation (CPR) that passes the patient's blood through a machine in a process to oxygenate the blood supply.
| Study group | Role | What they receive |
|---|---|---|
| ECPR and ECMO | Patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR). Receives: Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome after 30 days (CPC score)
Assessment of the neurological status of patients 30 days after the event using the Cerebral Performance Category (CPC) scale, which measures the extent of neurological impairment:
- CPC 1 = good neurological condition
- CPC 2 = mild impairment
- CPC 3-5 = serious impairment, vegetative state or death The primary endpoint of the study is the proportion of patients with a favourable neurological outcome (CPC 1-2).
Measured: 30 days
Secondary outcomes (3)
Time from collapse to initiation of ECMO
Measuring the time (in minutes) from patient collapse to ECMO initiation. The aim is to analyse how this time affects neurological outcome.
Measured: Up to 2 hours
Transport time to the ECMO centre
Measurement of the time (in minutes) from the arrival of the Emergency Medical Services (EMS) at the scene to the admission of the patient to the ECMO centre.
Measured: Up to 2 hours
Arrival time for the mobile ECMO team to the scene
Time interval (in minutes) from activation of the mobile ECMO team to its arrival at the scene. The aim is to evaluate the effectiveness of the model and the potential time benefit of intervention in the field.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 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 With Successful ResuscitationStudies 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
- Nela Walachová, Mgr., Principal investigator, University Hospital Ostravs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009652
- Sponsor's protocol ID
- CEPR-01-ECPR
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 6 Jun 2025
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for the Organisation of the Procedure for Extracorporeal Cardiopulmonary Resuscitation of Patients With Sudden Cardiac Arrest in the Pre-hospital Environment of the Moravian-Silesian Region
- ClinicalTrials.gov ID
- NCT07009652
- Acronym / sponsor ID
- CEPR-01-ECPR
- Keywords
- cardiac arrest, extracorporeal membrane oxygenation, out-of-hospital cardiac arrest, extracorporeal 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
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 6 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.
This study evaluates the feasibility of implementing a mobile extracorporeal membrane oxygenation (ECMO) team and optimizing patient transport logistics.
Detailed description
The aim of the study is to improve neurological outcomes in out-of-hospital cardiac arrest (OHCA) cases in the Moravian-Silesian Region. By analysing regional epidemiological and demographic data, the project aims to identify key factors for reducing the time from collapse to the initiation of ECMO and to support the development of effective protocols for extracorporeal cardiopulmonary resuscitation (ECPR).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECPR and ECMO | – | Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)Patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR). |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients indicated for ECPR after out-of-hospital cardiac arrest, for whom transport of the patient to an ECMO centre or deployment of an ECMO team is logistically manage-able.
Key inclusion criteria (2 listed)
- out-of-hospital cardiac arrest
- indication for ECPR
Key exclusion criteria (2 listed)
- death at the scene of the accident
- withdrawal of the informed consent
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 cardiopulmonary resuscitation (ECPR)Extracorporeal cardiopulmonary resuscitation (commonly known as ECPR) is a method of cardiopulmonary resuscitation (CPR) that passes the patient's blood through a machine in a process to oxygenate the blood supply. | Procedure or surgery | ECPR and ECMO |
Primary outcome
Neurological outcome after 30 days (CPC score)
Time frame: 30 days
Assessment of the neurological status of patients 30 days after the event using the Cerebral Performance Category (CPC) scale, which measures the extent of neurological impairment: * CPC 1 = good neurological condition * CPC 2 = mild impairment * CPC 3-5 = serious impairment, vegetative state or death The primary endpoint of the study is the proportion of patients with a favourable neurological outcome (CPC 1-2).
3 secondary outcomes
Time from collapse to initiation of ECMO
Time frame: Up to 2 hours
Transport time to the ECMO centre
Time frame: Up to 2 hours
Arrival time for the mobile ECMO team to the scene
Time frame: Up to 2 hours
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 6 Jun 2025.
- 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.
Nela Walachová, Mgr. principal investigator
University Hospital Ostravs
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 With Successful Resuscitation and Cardiac Arrest, Cause Unspecified, 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 2 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 6 Jun 2025. 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?
Neurological outcome after 30 days (CPC score) (time frame: 30 days). 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 6 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.