Out of Hospital Cardiac ArrestRACENCT06789978
Rapid Prehospital ACcess to ECPR in Prague
A study testing Extracorporeal cardiopulmonary resuscitation (ECPR) in people with Out of Hospital Cardiac Arrest and Extracorporeal Cardiopulmonary Resuscitation, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Out of Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation
- What is being tested?
- Extracorporeal cardiopulmonary resuscitation (ECPR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Jan 2025to 16 Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- Estimated age 18-70 years
- Refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity)
- Witnessed cardiac arrest
- ECPR team available
- ECPR team alert within 20 minutes from the emergency call
Who cannot join
- Unwitnessed cardiac arrest
- Asystole
- ETCO2 less than 10 mmHg upon ECPR team arrival
- Known limitations of intensive care (Do Not Resuscitate - DNR status)
- Known severe neurological impairment prior to cardiac arrest (mRS 4-6)
- Suspected or known pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital in Prague
Prague, Czechia, 12800
Jan Belohlavek, MD, PhD, +420724371594, jan.belohlavek@vfn.cz
Daniel Rob, MD, PhD, +420721932067, daniel.rob@vfn.cz
About this study
Official title: Prehospital Extracorporeal Cardiopulmonary Resuscitation: A Pilot Study in Prague
A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA
Read the detailed description
The aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ECPR) system for refractory out-of-hospital cardiac arrest (OHCA) in Prague, compared to a historical cohort of in-hospital ECPR recipients from the Prague OHCA trial.
- Being tested
- Extracorporeal cardiopulmonary resuscitation (ECPR)
- Keywords
- Cardiac arrest, ECPR, ECMO, Prehospital
- 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 cardiopulmonary resuscitation (ECPR)Other
Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)
| Study group | Role | What they receive |
|---|---|---|
| Prehospital extracorporeal cardiopulmonary resuscitation (ECPR) | Experimental | Prehospital ECPR will include all patients who enter the study and receive ECPR.
The historical control group will consist of patients from the Prague OHCA study who received in-hospital ECPR and fulfilled all relevant inclusion and exclusion criteria for this study. Receives: Other: Extracorporeal cardiopulmonary resuscitation (ECPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from collapse to ECPR
Time from collapse to start of VA ECMO flow
Measured: Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes)
Secondary outcomes (2)
All cause survival at 30-days
Kaplan Meier analysis, log-rank test
Measured: 30-days
Modified Rankin Scale at 30-days
Modified Rankin Scale (mRS) at 30 days: mRS 0-3 is considered a good outcome, and mRS 4-6 is considered a poor outcome.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start20 Jan 2025
- Primary completion16 Jun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out of Hospital Cardiac ArrestStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm interventional study with a historical control from Prague OHCA study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Bělohlávek, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789978
- Sponsor's protocol ID
- 134/23 S-IV
- Acronym
- RACE
- Status last verified
- Feb 2025
- First submitted
- 16 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and analyzed in this study will be available from the principal investigators upon reasonable request.
Publications
Rob D, Trhlikova S, Pudil J, Kavalkova P, Svitekova K, Mockova E, Dusik M, Macoun J, Frybova T, Fichtl J, Mlejnsky F, Spicak J, Belohlavek J. Prehospital extracorporeal cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest: a protocol for the Rapid prehospital ACcess to ECPR in Prague (RACE Prague) single-arm pilot feasibility study. Resusc Plus. 2026 Sep 24;32:101504. doi: 10.1016/j.resplu.2026.101504. eCollection 2026 Nov.
PubMed 42893205
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Extracorporeal Cardiopulmonary Resuscitation: A Pilot Study in Prague
- ClinicalTrials.gov ID
- NCT06789978
- Acronym / sponsor ID
- RACE / 134/23 S-IV
- Keywords
- Cardiac arrest, ECPR, ECMO, Prehospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 23 Jan 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.
A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA
Detailed description
The aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ECPR) system for refractory out-of-hospital cardiac arrest (OHCA) in Prague, compared to a historical cohort of in-hospital ECPR recipients from the Prague OHCA trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm interventional study with a historical control from Prague OHCA study
| Arm | Type | Receives |
|---|---|---|
| Prehospital extracorporeal cardiopulmonary resuscitation (ECPR) | Experimental | Other: Extracorporeal cardiopulmonary resuscitation (ECPR)Prehospital ECPR will include all patients who enter the study and receive ECPR. The historical control group will consist of patients from the Prague OHCA study who received in-hospital ECPR and fulfilled all relevant inclusion and exclusion criteria for this study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Estimated age 18-70 years
- Refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity)
- Witnessed cardiac arrest
- ECPR team available
- ECPR team alert within 20 minutes from the emergency call
Key exclusion criteria (6 listed)
- Unwitnessed cardiac arrest
- Asystole
- ETCO2 less than 10 mmHg upon ECPR team arrival
- Known limitations of intensive care (Do Not Resuscitate - DNR status)
- Known severe neurological impairment prior to cardiac arrest (mRS 4-6)
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)Prehospital extracorporeal cardiopulmonary resuscitation (ECPR) | Other | Prehospital extracorporeal cardiopulmonary resuscitation (ECPR) |
Primary outcome
Time from collapse to ECPR
Time frame: Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes)
Time from collapse to start of VA ECMO flow
2 secondary outcomes
All cause survival at 30-days
Time frame: 30-days
Modified Rankin Scale at 30-days
Time frame: 30-days
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 14 Feb 2025.
- Derived from this study: PubMed 42893205Rob D, Trhlikova S, Pudil J, Kavalkova P, Svitekova K, Mockova E, Dusik M, Macoun J, Frybova T, Fichtl J, Mlejnsky F, Spicak J, Belohlavek J. Prehospital extracorporeal cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest: a protocol for the Rapid prehospital ACcess to ECPR in Prague (RACE Prague) single-arm pilot feasibility study. Resusc Plus. 2026 Sep 24;32:101504. doi: 10.1016/j.resplu.2026.101504. eCollection 2026 Nov.
- Individual participant dataSharing planned: Yes. The datasets used and analyzed in this study will be available from the principal investigators upon reasonable 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal cardiopulmonary resuscitation (ECPR) in people with Out of Hospital Cardiac Arrest and Extracorporeal Cardiopulmonary Resuscitation, run by General University Hospital, Prague at 1 site 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 6 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jan Belohlavek, MD, PhD (420724371594, jan.belohlavek@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from collapse to ECPR (time frame: Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789978, which also lists 1 linked publication.
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 14 Feb 2025.