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

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ClinicalTrials.gov Identifier: NCT04620070
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : June 24, 2022
Sponsor:
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
Information provided by (Responsible Party):
Dinis Reis Miranda, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Cardiac Arrest Procedure: ECPR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped-wedge design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation (ECPR) During Refractory Out-of-Hospital Cardiac Arrest
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Hospital Survival [ Time Frame: Hospital discharge (on average 6 weeks) ]
    (% patients surviving hospital discharge)

  2. Favourable neurological outcome (CPC 1-2) [ Time Frame: 6 months after cardiac arrest ]
    (% of patients at least performing daily life activities independent)

  3. Favourable neurological outcome (CPC 1-2) [ Time Frame: 12 months after cardiac arrest ]
    (% of patients at least performing daily life activities independent)

  4. Costs/QALY [ Time Frame: 6 months after cardiac arrest ]
    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)

  5. Costs/QALY [ Time Frame: 12 months after cardiac arrest ]
    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 :
  1. Survival prehospital ECPR vs ECPR at the hospital vs no ECPR [ Time Frame: Hospital discharge (on average 6 weeks after cardiac arrest) ]
  2. survival OHCA treated by paramedic (historic control) only vs HEMS physician [ Time Frame: Hospital discharge (on average 6 weeks after cardiac arrest) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620070


Contacts
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Contact: Dinis Reis Miranda, MD.PhD +31107040704 d.dosreismiranda@erasmusmc.nl
Contact: Samir Ali, MD +31107040704 s.ali@erasmusmc.nl

Locations
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Netherlands
Amsterdam UMC Recruiting
Amsterdam, Netherlands
Contact: Hans van Schuppen, MD    +3120566273599    j.l.vanschuppen@amsterdamumc.nl   
UMCG Recruiting
Groningen, Netherlands
Contact: E Weelink    +3150-3615128    e.e.m.weelink@umcg.nl   
Radboud Recruiting
Nijmegen, Netherlands
Contact: Geert-Jan van Geffen    +31243611111    Geert-Jan.vanGeffen@radboudumc.nl   
ErasmusMC Recruiting
Rotterdam, Netherlands, 3015GD
Contact: Dinis Reis Miranda, MD, PhD    +31628122208    d.dosreismiranda@erasmusmc.nl   
Contact: Samir Ali, MD    +31107040704    s.ali@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
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
Investigators
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Principal Investigator: Dinis Reis Miranda Erasmus Medical Center
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Responsible Party: Dinis Reis Miranda, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04620070    
Other Study ID Numbers: NL73073.078.20
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Dinis Reis Miranda, Erasmus Medical Center:
ECPR
prehospital ECPR
out of hospital cardiac arrest
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases