Extracorporeal Membrane OxygenationON-SCENENCT04620070
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest
A study testing ECPR in people with Extracorporeal Membrane Oxygenation and Cardiac Arrest, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial summary
Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Cardiac Arrest
- What is being tested?
- ECPR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 4 sitesNetherlands
- Study dates
- 15 Oct 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Age between 18 and 50 years, known or as estimated at inclusion by the HEMS physician.
- Witnessed arrest (last seen well <5 min), OR signs of life (gasping, movement)
- Initial rhyme is VT/VF OR Suspected of having a pulmonary embolism
- Refractory cardiac arrest lasting longer than 20 minutes and shorter than 45 min
- If age is not exactly known at inclusion and is estimated by the HEMS physician between 18 and 50 years but finally the patient appears to be younger or older, the patient will not be excluded.
Who cannot join
- - CO2 et<1.2 kPa (10 mmHg) during CPR
- No clear echographic visualisation of either the femoral artery or the femoral vein.
- Expected time from collapse to arrival at an ECPR center with a direct available ECPR team is less than 30 min.
- The following patients will be withdrawn after initial inclusion as soon as the following information becomes available:
- Known malignancy
- Known intracranial haemorrhage/ischemia <6 weeks
Show all 9Show fewer
- Care dependent for daily activities before arrest
- Patients with a "do not resuscitate" order, which was not known at time of the arrest.
- Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Amsterdam UMC
Amsterdam
UMCG
Groningen
Radboud
Nijmegen
ErasmusMC
Rotterdam, 3015GD
About this study
Official title: ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation (ECPR) During Refractory Out-of-Hospital Cardiac Arrest
Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.
Read the detailed description
Rationale: Approximately half of all cardiac arrest patients achieve return of spontaneous circulation (ROSC) within 10 minutes. However, If ROSC is not achieved within 20 minutes, favourable neurological outcome is rare. Currently, patients without ROSC at scene die at scene, or are transported (while still in cardiac arrest) to the hospital. In the hospital, advanced life support is continued, or, when presented to selected hospitals capable for this strategy, patients receive Extracorporeal CardioPulmonary Resuscitation (ECPR). ECPR is a strategy in which a miniaturized heart-lung machine (similar to that used in open-heart surgery) is attached to the patient. Nowadays, the greatest drawback transporting OHCA patients with refractory arrest to the hospital are the low quality of thorax compression during transport and long time needed to arrive in the hospital, in part because not all hospitals are able to provide this treatment. In the Netherlands, Helicopter Emergency Medical Services (HEMS) deliver highly specialized medical care to trauma and non-trauma patients, covering the entire country.
Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.
Objective: To improve survival to hospital discharge and costs/QALY in young patients with OHCA by decreasing the time in cardiac arrest by initiating ECPR on scene.
- Being tested
- ECPR
- Keywords
- ECPR, prehospital ECPR, out of hospital cardiac arrest
- 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.
ECPRProcedure or surgery
Application of prehospital ECPR
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | In the Netherlands, out-of-hospital cardiac arrest (OHCA) is managed by paramedics. In this study, in the conventional arm, OHCA is managed by a physician of the Helicopter Emergency Medical Services (HEMS), but without the possibility of prehospital ECPR. |
| Intervention group | Experimental | OHCA managed by the physician of the HEMS team, but with the possibility of prehospital ECPR. Receives: Procedure: ECPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Survival
(% patients surviving hospital discharge)
Measured: Hospital discharge (on average 6 weeks)
Secondary outcomes (2)
Favourable neurological outcome (CPC 1-2)
(% of patients at least performing daily life activities independent)
Measured: 6 months after cardiac arrest
Survival prehospital ECPR vs ECPR at the hospital vs no ECPR
Measured: Hospital discharge (on average 6 weeks after cardiac arrest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start15 Oct 2021
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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 Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, University Medical Center Groningen, Leiden University Medical Center, Haga Hospital, St. Antonius Hospital, Isala, Catharina Ziekenhuis Eindhoven, Amphia ziekenhuis
- Responsible party
- Principal investigator, Dinis Reis Miranda, Erasmus Medical Center
- Investigators
- Dinis Reis Miranda, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620070
- Sponsor's protocol ID
- NL73073.078.20
- Acronym
- ON-SCENE
- Status last verified
- Dec 2025
- First submitted
- 26 Oct 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali S, Moors X, van Schuppen H, Mommers L, Weelink E, Meuwese CL, Kant M, van den Brule J, Kraemer CE, Vlaar APJ, Akin S, Lansink-Hartgring AO, Scholten E, Otterspoor L, de Metz J, Delnoij T, van Lieshout EMM, Houmes RJ, Hartog DD, Gommers D, Dos Reis Miranda D. A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study. Scand J Trauma Resusc Emerg Med. 2024 Apr 17;32(1):31. doi: 10.1186/s13049-024-01198-x.
PubMed 38632661
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation (ECPR) During Refractory Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04620070
- Acronym / sponsor ID
- ON-SCENE / NL73073.078.20
- Keywords
- ECPR, prehospital ECPR, out of hospital cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, University Medical Center Groningen, Leiden University Medical Center, Haga Hospital, St. Antonius Hospital, Isala, Catharina Ziekenhuis Eindhoven, Amphia ziekenhuis
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 6 Nov 2020 (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.
Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.
Detailed description
Rationale: Approximately half of all cardiac arrest patients achieve return of spontaneous circulation (ROSC) within 10 minutes. However, If ROSC is not achieved within 20 minutes, favourable neurological outcome is rare. Currently, patients without ROSC at scene die at scene, or are transported (while still in cardiac arrest) to the hospital. In the hospital, advanced life support is continued, or, when presented to selected hospitals capable for this strategy, patients receive Extracorporeal CardioPulmonary Resuscitation (ECPR). ECPR is a strategy in which a miniaturized heart-lung machine (similar to that used in open-heart surgery) is attached to the patient. Nowadays, the greatest drawback transporting OHCA patients with refractory arrest to the hospital are the low quality of thorax compression during transport and long time needed to arrive in the hospital, in part because not all hospitals are able to provide this treatment. In the Netherlands, Helicopter Emergency Medical Services (HEMS) deliver highly specialized medical care to trauma and non-trauma patients, covering the entire country.
Hypothesis: Implantation of on-scene ECPR by the HEMS teams in patients with sustained out-of-hospital cardiac arrest, results in the rapid return of circulation and, thus, improved survival and less neurological impairment, which is associated with lower health care costs.
Objective: To improve survival to hospital discharge and costs/QALY in young patients with OHCA by decreasing the time in cardiac arrest by initiating ECPR on scene.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –In the Netherlands, out-of-hospital cardiac arrest (OHCA) is managed by paramedics. In this study, in the conventional arm, OHCA is managed by a physician of the Helicopter Emergency Medical Services (HEMS), but without the possibility of prehospital ECPR. |
| Intervention group | Experimental | Procedure: ECPROHCA managed by the physician of the HEMS team, but with the possibility of prehospital ECPR. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Age between 18 and 50 years, known or as estimated at inclusion by the HEMS physician.
- Witnessed arrest (last seen well <5 min), OR signs of life (gasping, movement)
- Initial rhyme is VT/VF OR Suspected of having a pulmonary embolism
- Refractory cardiac arrest lasting longer than 20 minutes and shorter than 45 min
- If age is not exactly known at inclusion and is estimated by the HEMS physician between 18 and 50 years but finally the patient appears to be younger or older, the patient will not be excluded.
Key exclusion criteria (9 listed)
- - CO2 et<1.2 kPa (10 mmHg) during CPR
- No clear echographic visualisation of either the femoral artery or the femoral vein.
- Expected time from collapse to arrival at an ECPR center with a direct available ECPR team is less than 30 min.
- The following patients will be withdrawn after initial inclusion as soon as the following information becomes available:
- Known malignancy
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 |
|---|---|---|
| ECPRApplication of prehospital ECPR | Procedure or surgery | Intervention group |
Primary outcome
Hospital Survival
Time frame: Hospital discharge (on average 6 weeks)
(% patients surviving hospital discharge)
2 secondary outcomes
Favourable neurological outcome (CPC 1-2)
Time frame: 6 months after cardiac arrest
Survival prehospital ECPR vs ECPR at the hospital vs no ECPR
Time frame: Hospital discharge (on average 6 weeks after cardiac arrest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 38632661Ali S, Moors X, van Schuppen H, Mommers L, Weelink E, Meuwese CL, Kant M, van den Brule J, Kraemer CE, Vlaar APJ, Akin S, Lansink-Hartgring AO, Scholten E, Otterspoor L, de Metz J, Delnoij T, van Lieshout EMM, Houmes RJ, Hartog DD, Gommers D, Dos Reis Miranda D. A national multi centre pre-hospital ECPR stepped wedge study; design and rationale of the ON-SCENE study. Scand J Trauma Resusc Emerg Med. 2024 Apr 17;32(1):31. doi: 10.1186/s13049-024-01198-x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dinis Reis Miranda principal investigator
Erasmus Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECPR in people with Extracorporeal Membrane Oxygenation and Cardiac Arrest, run by Erasmus Medical Center at 4 sites in Netherlands.
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 9 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: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Survival (time frame: Hospital discharge (on average 6 weeks)). 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 NCT04620070, 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 24 Dec 2025.