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

NCT04620070 | Completed

• 1 other identifier: NL73073.078.20
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cardiac Arrest; Extracorporeal Membrane Oxygenation

Keywords

ECPR; prehospital ECPR; out of hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Hospital Survival

  (% patients surviving hospital discharge)

  Hospital discharge (on average 6 weeks)

Secondary Outcomes (2)

• Favourable neurological outcome (CPC 1-2)

  6 months after cardiac arrest

• Survival prehospital ECPR vs ECPR at the hospital vs no ECPR

  Hospital discharge (on average 6 weeks after cardiac arrest)

Study Arms (2)

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.

Procedure: ECPR

Interventions

ECPR PROCEDURE

Application of prehospital ECPR

Intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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.
• 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.

Sponsors & Collaborators

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

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Radboud

Nijmegen, Netherlands

Location

ErasmusMC

Rotterdam, 3015GD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38632661 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dinis Reis Miranda

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped-wedge design

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: October 15, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)