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CompletedNCT04620070ON-SCENEUpdated Dec 24, 2025

ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest

An interventional study of ECPR in Extracorporeal Membrane Oxygenation and Cardiac Arrest, sponsored by Erasmus Medical Center. Completed at 4 sites in Netherlands. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
221
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Extracorporeal Membrane Oxygenation
  • Cardiac Arrest

Keywords

  • ECPR
  • prehospital ECPR
  • out of hospital cardiac arrest
03

In context

Heart Arrest

965 studies on the registry are indexed under Heart Arrest; 225 are open to participants now.

This study's enrollment of 221 is above the median of 100 across 556 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • - 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.

Exclusion criteria

Exclusion Criteria:

  • - 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
221 participants (actual)

Study arms

  • No intervention
    Conventional

    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.

  • Experimental
    Intervention group

    OHCA managed by the physician of the HEMS team, but with the possibility of prehospital ECPR.

    Procedure: ECPR

Interventions

  • ProcedureECPR

    Application of prehospital ECPR

06

What researchers measure

Primary outcomes

  1. Hospital Survival

    (% patients surviving hospital discharge)

    Time frame: Hospital discharge (on average 6 weeks)

Secondary outcomes

  1. Favourable neurological outcome (CPC 1-2)

    (% of patients at least performing daily life activities independent)

    Time frame: 6 months after cardiac arrest

  2. Survival prehospital ECPR vs ECPR at the hospital vs no ECPR

    Time frame: Hospital discharge (on average 6 weeks after cardiac arrest)

07

Study locations

4 sites
  • Amsterdam UMC
    Amsterdam, Netherlands
  • UMCG
    Groningen, Netherlands
  • Radboud
    Nijmegen, Netherlands
  • ErasmusMC
    Rotterdam, 3015GD, Netherlands
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04620070
Lead sponsor
Erasmus Medical Center
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
Dinis Reis Miranda (Principal Investigator, Erasmus Medical Center) — Principal investigator
First posted
Nov 6, 2020
Start date
Oct 15, 2021
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025
Last update
Dec 24, 2025

Study contacts

Dinis Reis Miranda
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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