On Scene ECPR in Ostrava

University Hospital Ostrava

Status: Enrolling

Conditions: Cardiac Arrest (CA); Cardiogenic Shock

Treatments: Procedure: Transfer with ongoing mechanical chest compression to hospital followed by hospital ECMO cannulation; Procedure: Prehospital ECMO cannulation on scene of cardiac arrest

Study type: Interventional

Funder types: Other

Identifiers

NCT07374289

FNO-KARIM-On-Scene-ECPR

Details and patient eligibility

About

On-scene extracorporeal pulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA) seems to speed up the start of extracorporeal membrane oxygenation (ECMO) and shorten low flow during cardiopulmonary resuscitation (CPR) in case of refractory cardiac arrest. The primary goal is to verify the benefit of on-scene ECPR in terms of shortening the collapse-to-ECMO interval. The secondary goal is to compare outcomes in the on-scene ECPR group with hospital cannulation.

Full description

ECPR is a life-saving method for a selected group of patients who are refractory to standard resuscitation procedures. With the appropriate use of ECPR, it is possible to achieve a significant improvement in survival with good neurological outcomes even in patients who would otherwise die. The ECMO Centre Ostrava has been providing ECPR for OHCA since 2022 with cannulation in the hospital after prior transport from the scene under continuous resuscitation. A good neurological outcome is achieved in approximately 29% of patients, even though the collapse-ECMO interval is around 75 minutes. Shortening this interval, which is associated with improved outcomes, is possible by using a mobile team that per-forms cannulation directly on scene. Mobile ECPR will be carried out in cooperation with the Ostrava University Hospital and the Moravian-Silesian Region Emergency Medical Service. The primary objective is to verify the benefit of on-scene ECPR in terms of shortening the collapse-ECMO interval. The secondary objective is to compare the outcome in the on-scene ECPR group with hospital cannulation.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presumed cardiac aetiology of the cardiac arrest
• Witnessed collapse
• Bystander CPR
• Estimated age ≤ 70 years
• Body weight ≥15 Kg

Exclusion criteria

• Known terminal malignant disease
• Known terminal chronic disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

ECPR on scene

Experimental group

Description:

On-scene ECPR cannulation by mobile ECMO team according to protocol if the location of the arrest and circumstances appear to be suitable (distance from the ECMO centre, transport logistics, in an ambulance/at home, etc.)

Treatment:

Procedure: Prehospital ECMO cannulation on scene of cardiac arrest

ECPR in hospital

Active Comparator group

Description:

Hospital ECPR cannulation at Emergency Department by ECMO team accord-ing to protocol if a on scene ECPR call-out was not indicated.

Treatment:

Procedure: Transfer with ongoing mechanical chest compression to hospital followed by hospital ECMO cannulation