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Completed

NCT Number: NCT04620070

ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation 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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • - 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.

Treatment and study plan

ECPR

Procedure

Application of prehospital ECPR

Primary outcomes

  1. Hospital Survival

    Time frame: Hospital discharge (on average 6 weeks)

    (% patients surviving hospital discharge)

Secondary outcomes

  1. Favourable neurological outcome (CPC 1-2)

    Time frame: 6 months after cardiac arrest

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

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

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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amphia ziekenhuis
  • Catharina Ziekenhuis Eindhoven
  • Haga Hospital
  • Isala
  • Leiden University Medical Center
  • Radboud University Medical Center
  • St. Antonius Hospital
  • University Medical Center Groningen

Registry information

Official study title

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

Acronym: ON-SCENE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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