Wroclaw Out-Of-Hospital Cardiac Arrest Registry

NCT05132387 | Recruiting

• 1 other identifier: 327/2021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Cardiac arrest, ECMO, ECMO-CPR

Outcome Measures

Primary Outcomes (1)

• mortality

  all cause mortality

  1 month

Secondary Outcomes (1)

• degree of disability

  3 and 6 months after index event

Study Arms (1)

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

Interventions

ECMO assisted CPR in out-of-hospital cardiac arrest OTHER

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.

Out-of-hospital cardiac arrest

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Wroclaw Emergency Medical Services: collaborator

Study Sites (1)

Wroclaw University Hostpital

Wroclaw, 50-556, Poland

RECRUITING

Related 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.

  PMID: 32550730 BACKGROUND

• 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.

  PMID: 33197396 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wiktor Kuliczkowski, MD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiktor Kuliczkowski, MD

CONTACT

+ 48 603 707 093; wiktor.kuliczkowski@umw.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Cardiac Catheterisation Laboratory

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: October 25, 2021
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

PL (1)