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

Primary Purpose

Extracorporeal Membrane Oxygenation, Cardiac Arrest

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ECPR
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporeal Membrane Oxygenation focused on measuring ECPR, prehospital ECPR, out of hospital cardiac arrest

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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The following patients will be withdrawn after initial inclusion as soon as the following information becomes available: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.

Sites / Locations

  • Amsterdam UMCRecruiting
  • UMCGRecruiting
  • RadboudRecruiting
  • ErasmusMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional

Intervention group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Hospital Survival
(% patients surviving hospital discharge)
Favourable neurological outcome (CPC 1-2)
(% of patients at least performing daily life activities independent)
Favourable neurological outcome (CPC 1-2)
(% of patients at least performing daily life activities independent)
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)
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)

Secondary Outcome Measures

Survival prehospital ECPR vs ECPR at the hospital vs no ECPR
survival OHCA treated by paramedic (historic control) only vs HEMS physician

Full Information

First Posted
October 26, 2020
Last Updated
October 21, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT04620070
Brief Title
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest
Acronym
ON-SCENE
Official Title
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation (ECPR) During Refractory Out-of-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Membrane Oxygenation, Cardiac Arrest
Keywords
ECPR, prehospital ECPR, out of hospital cardiac arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
OHCA managed by the physician of the HEMS team, but with the possibility of prehospital ECPR.
Intervention Type
Procedure
Intervention Name(s)
ECPR
Intervention Description
Application of prehospital ECPR
Primary Outcome Measure Information:
Title
Hospital Survival
Description
(% patients surviving hospital discharge)
Time Frame
Hospital discharge (on average 6 weeks)
Title
Favourable neurological outcome (CPC 1-2)
Description
(% of patients at least performing daily life activities independent)
Time Frame
6 months after cardiac arrest
Title
Favourable neurological outcome (CPC 1-2)
Description
(% of patients at least performing daily life activities independent)
Time Frame
12 months after cardiac arrest
Title
Costs/QALY
Description
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)
Time Frame
6 months after cardiac arrest
Title
Costs/QALY
Description
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)
Time Frame
12 months after cardiac arrest
Secondary Outcome Measure Information:
Title
Survival prehospital ECPR vs ECPR at the hospital vs no ECPR
Time Frame
Hospital discharge (on average 6 weeks after cardiac arrest)
Title
survival OHCA treated by paramedic (historic control) only vs HEMS physician
Time Frame
Hospital discharge (on average 6 weeks after cardiac arrest)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dinis Reis Miranda, MD.PhD
Phone
+31107040704
Email
d.dosreismiranda@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Samir Ali, MD
Phone
+31107040704
Email
s.ali@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinis Reis Miranda
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans van Schuppen, MD
Phone
+3120566273599
Email
j.l.vanschuppen@amsterdamumc.nl
Facility Name
UMCG
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E Weelink
Phone
+3150-3615128
Email
e.e.m.weelink@umcg.nl
Facility Name
Radboud
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geert-Jan van Geffen
Phone
+31243611111
Email
Geert-Jan.vanGeffen@radboudumc.nl
Facility Name
ErasmusMC
City
Rotterdam
ZIP/Postal Code
3015GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinis Reis Miranda, MD, PhD
Phone
+31628122208
Email
d.dosreismiranda@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Samir Ali, MD
Phone
+31107040704
Email
s.ali@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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