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

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Cardiac Arrest
• Intervention / Treatment: Procedure: ECPR

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 Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dinis Reis Miranda, MD.PhD; Phone Number: +31107040704; Email: d.dosreismiranda@erasmusmc.nl
• Study Contact Backup: Name: Samir Ali, MD; Phone Number: +31107040704; Email: s.ali@erasmusmc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Hans van Schuppen, MD; Phone Number: +3120566273599; Email: j.l.vanschuppen@amsterdamumc.nl
  • Groningen, Netherlands
    • Recruiting
    • UMCG
    • Contact: E Weelink; Phone Number: +3150-3615128; Email: e.e.m.weelink@umcg.nl
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud
    • Contact: Geert-Jan van Geffen; Phone Number: +31243611111; Email: Geert-Jan.vanGeffen@radboudumc.nl
  • Rotterdam, Netherlands, 3015GD
    • Recruiting
    • ErasmusMC
    • Contact: Samir Ali, MD; Phone Number: +31107040704; Email: s.ali@erasmusmc.nl
    • Contact: Dinis Reis Miranda, MD, PhD; Phone Number: +31628122208; Email: d.dosreismiranda@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Application of prehospital ECPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Survival	(% patients surviving hospital discharge)	Hospital discharge (on average 6 weeks)
Favourable neurological outcome (CPC 1-2)	(% of patients at least performing daily life activities independent)	6 months after cardiac arrest
Favourable neurological outcome (CPC 1-2)	(% of patients at least performing daily life activities independent)	12 months after cardiac arrest
Costs/QALY	Costs related to prehospital ECPR per Quality Adjusted Life Year (Quality of Life assessed by EQ-5D questionnaire). Stated as incremental costs in Euro's ranging from 0-100.000 euro)	6 months after cardiac arrest
Costs/QALY	Costs related to prehospital ECPR per Quality Adjusted Life Year (Quality of Life assessed by EQ-5D questionnaire). Stated as incremental costs in Euro's ranging from 0-100.000 euro)	12 months after cardiac arrest

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival prehospital ECPR vs ECPR at the hospital vs no ECPR	Hospital discharge (on average 6 weeks after cardiac arrest)
survival OHCA treated by paramedic (historic control) only vs HEMS physician	Hospital discharge (on average 6 weeks after cardiac arrest)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Radboud University Medical Center; University Medical Center Groningen; Catharina Ziekenhuis Eindhoven; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); St. Antonius Hospital; Leiden University Medical Center; Haga Hospital; Isala; Amphia ziekenhuis
• Investigators: Principal Investigator: Dinis Reis Miranda, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: out of hospital cardiac arrest; ECPR; prehospital ECPR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: NL73073.078.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes