Clinical trial NCT05132387: Wroclaw Out-Of-Hospital Cardiac Arrest Registry
Official title: Wroclaw Out-Of-Hospital Cardiac Arrest Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Cardiac arrest, ECMO, ECMO-CPR
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Wroclaw Emergency Medical Services
First posted: 2021-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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%.

Eligibility criteria: 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

Primary outcomes:
measure: mortality
timeFrame: 1 month
Secondary outcomes:
measure: degree of disability
timeFrame: 3 and 6 months after index event
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw University Hostpital
Study officials:
affiliation: Wroclaw Medical University
name: Wiktor Kuliczkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.