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

Cardiac Arrest Clinical Trial

— ON-SCENE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620070
• Other study ID #: NL73073.078.20
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: October 2023
• Source: Erasmus Medical Center
• Contact: Dinis Reis Miranda, MD.PhD
• Phone: +31107040704
• Email: d.dosreismiranda[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Extracorporeal Membrane Oxygenation
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• ECPR
Application of prehospital ECPR

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	UMCG	Groningen
Netherlands	Radboud	Nijmegen
Netherlands	ErasmusMC	Rotterdam

Sponsors (10)

Lead Sponsor	Collaborator
Erasmus Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amphia ziekenhuis, Catharina Ziekenhuis Eindhoven, Haga Hospital, Isala, Leiden University Medical Center, Radboud University Medical Center, St. Antonius Hospital, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Survival	(% patients surviving hospital discharge)	Hospital discharge (on average 6 weeks)
Primary	Favourable neurological outcome (CPC 1-2)	(% of patients at least performing daily life activities independent)	6 months after cardiac arrest
Primary	Favourable neurological outcome (CPC 1-2)	(% of patients at least performing daily life activities independent)	12 months after cardiac arrest
Primary	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
Primary	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	Survival prehospital ECPR vs ECPR at the hospital vs no ECPR		Hospital discharge (on average 6 weeks after cardiac arrest)
Secondary	survival OHCA treated by paramedic (historic control) only vs HEMS physician		Hospital discharge (on average 6 weeks after cardiac arrest)