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
|Condition or disease||Intervention/treatment||Phase|
|Extracorporeal Membrane Oxygenation Cardiac Arrest||Procedure: ECPR||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Stepped-wedge design|
|Masking:||None (Open Label)|
|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|
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.
Application of prehospital ECPR
- Hospital Survival [ Time Frame: Hospital discharge (on average 6 weeks) ](% patients surviving hospital discharge)
- Favourable neurological outcome (CPC 1-2) [ Time Frame: 6 months after cardiac arrest ](% of patients at least performing daily life activities independent)
- Favourable neurological outcome (CPC 1-2) [ Time Frame: 12 months after cardiac arrest ](% of patients at least performing daily life activities independent)
- 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)
- 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)
- Survival prehospital ECPR vs ECPR at the hospital vs no ECPR [ Time Frame: Hospital discharge (on average 6 weeks after cardiac arrest) ]
- survival OHCA treated by paramedic (historic control) only vs HEMS physician [ Time Frame: Hospital discharge (on average 6 weeks after cardiac arrest) ]
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
|Contact: Dinis Reis Miranda, MD.PhDemail@example.com|
|Contact: Samir Ali, MDfirstname.lastname@example.org|
|Contact: Hans van Schuppen, MD +3120566273599 email@example.com|
|Contact: E Weelink +3150-3615128 firstname.lastname@example.org|
|Contact: Geert-Jan van Geffen +31243611111 Geert-Jan.vanGeffen@radboudumc.nl|
|Rotterdam, Netherlands, 3015GD|
|Contact: Dinis Reis Miranda, MD, PhD +31628122208 email@example.com|
|Contact: Samir Ali, MD +31107040704 firstname.lastname@example.org|
|Principal Investigator:||Dinis Reis Miranda||Erasmus Medical Center|