Wroclaw Out-Of-Hospital Cardiac Arrest Registry

Out-Of-Hospital Cardiac Arrest Clinical Trial

— WOHCA  

Official title:

Wroclaw Out-Of-Hospital Cardiac Arrest Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132387
• Other study ID #: 327/2021
• Status: Recruiting
• Start date: October 25, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2023
• Source: Wroclaw Medical University
• Contact: Wiktor Kuliczkowski, MD
• Phone: + 48 603 707 093
• Email: wiktor.kuliczkowski[@]umw.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
Poland	Wroclaw University Hostpital	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Wroclaw Emergency Medical Services

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	all cause mortality	1 month
Secondary	degree of disability	Modified Rankin Scale of 3 or lower	3 and 6 months after index event