WOHCA: Wroclaw Out-Of-Hospital Cardiac Arrest Registry

• Sponsor: Wroclaw Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05132387
• Collaborator: Wroclaw Emergency Medical Services (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 38.2
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Wroclaw Out-Of-Hospital Cardiac Arrest Registry
• Actual Study Start Date: Oct 25, 2021
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. mortality [1 month]

   all cause mortality

Secondary Outcome Measures

1. degree of disability [3 and 6 months after index event]

   Modified Rankin Scale of 3 or lower

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wroclaw University Hostpital	Wroclaw		Poland	50-556

Sponsors and Collaborators

• Wroclaw Medical University
• Wroclaw Emergency Medical Services

Investigators

• Principal Investigator: Wiktor Kuliczkowski, MD, Wroclaw Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Sip M, Puślecki M, Kłosiewicz T, Zalewski R, Dąbrowski M, Ligowski M, Goszczyńska 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.
• 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.

• Responsible Party: Wiktor Kuliczkowski, Head of the Cardiac Catheterisation Laboratory, Wroclaw Medical University
• ClinicalTrials.gov Identifier: NCT05132387
• Other Study ID Numbers: 327/2021
• First Posted: Nov 24, 2021
• Last Update Posted: Dec 8, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wiktor Kuliczkowski, Head of the Cardiac Catheterisation Laboratory, Wroclaw Medical University: Cardiac arrest, ECMO, ECMO-CPR
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of Dec 8, 2021