Wroclaw Out-Of-Hospital Cardiac Arrest Registry

Recruiting

• Conditions: Out-Of-Hospital Cardiac Arrest
• Interventions: Other: ECMO assisted CPR in out-of-hospital cardiac arrest

• Registration Number: NCT05132387
• Lead Sponsor: Wroclaw Medical University

Brief Summary

The purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest.

Detailed Description

Patients with out-of-hospital cardiac arrest included in the program will be treated with extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation (CPR) with additional invasive procedures including coronary/pulmonary angiography and intervention. This type of treatment was not provided in institutionalized fashion in Wroclaw, Poland. Implementation of this program should improve survival in out-of-hospital cardiac arrest patients, which currently is less than 10%.

Study Timeline

• Study Start: 2021-10-25
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-10-31
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age < 60 years
• witnessed sudden cardiac arrest with immediate CPR
• supposed cardiac cause of the event
• ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) at first medical contact with 3 unsuccessful defibrillations (no ROSC)
• CPR conducted with Lund University Cardiopulmonary Assist System (LUCAS™)
• Estimated transfer time from the scene to the Emergency Department < 30 minutes.
• End tidal carbon dioxide (ETCO2) > 10 mmHg

Exclusion Criteria

• Total presumed time from 112 call to ECMO implantation longer than 60 minutes
• Age < 18 years old or > 60 years old;
• Non-shockable initial rhythm
• Unavailability of the automated CPR device
• Unavailability of the catheterisation laboratory
• Severe concomitant illness with decreased life expectancy
• Severe body injury
• Severe active bleeding
• Drowning
• Terminal cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Out-of-hospital cardiac arrest	ECMO assisted CPR in out-of-hospital cardiac arrest	Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw.

Primary Outcome Measures

Name	Time	Method
mortality	1 month	all cause mortality

Secondary Outcome Measures

Name	Time	Method
degree of disability	3 and 6 months after index event	Modified Rankin Scale of 3 or lower

Trial Locations

Locations (1)

Wroclaw University Hostpital; 🇵🇱 Wroclaw, Poland