Wroclaw Out-Of-Hospital Cardiac Arrest Registry (WOHCA)

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

Study Overview

• Status: Recruiting
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Other: ECMO assisted CPR in 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Wiktor Kuliczkowski, MD; Phone Number: + 48 603 707 093; Email: wiktor.kuliczkowski@umw.edu.pl

Study Locations

• Poland
  • Wroclaw, Poland, 50-556
    • Recruiting
    • Wroclaw University Hostpital
    • Contact: Wiktor Kuliczkowski, MD; Phone Number: + 48 603707093; Email: wiktor.kuliczkowski@umw.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw, Poland.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Out-of-hospital cardiac arrest; Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw.

Other: ECMO assisted CPR in out-of-hospital cardiac arrest; Patients included in the registry will be transferred during LUCAS assisted CPR by the Wroclaw Emergency Medical Services to the Emergency Department of the Wroclaw University Hospital where blood gasses will be assessed. If two or more of the following: end-tidal carbon dioxide (CO2) > 10 mm Hg, arterial partial pressure of oxygen (PaO2) >50 mm Hg or oxygen saturation >85%, and lactic acid <18 mmol/L will be fulfilled patient will be further transferred to the Cardiac Catheterization Laboratory for V-A ECMO implantation followed by coronary/pulmonary artery angiography and intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	all cause mortality	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of disability	Modified Rankin Scale of 3 or lower	3 and 6 months after index event

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Collaborators: Wroclaw Emergency Medical Services
• Investigators: Principal Investigator: Wiktor Kuliczkowski, MD, Wroclaw Medical University

Publications and helpful links

General Publications

• Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.
• Sip M, Puslecki M, Klosiewicz T, Zalewski R, Dabrowski M, Ligowski M, Goszczynska E, Paprocki C, Grygier M, Lesiak M, Jemielity M, Perek B. A concept for the development of a pioneer regional Out-of-Hospital Cardiac Arrest Program to improve patient outcomes. Kardiol Pol. 2020 Sep 25;78(9):875-881. doi: 10.33963/KP.15433. Epub 2020 Jun 16.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac arrest, ECMO, ECMO-CPR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 327/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No