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Recruiting

NCT Number: NCT05132387

Wroclaw Out-Of-Hospital Cardiac Arrest Registry

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

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wroclaw University Hostpital

Wroclaw, 50-556, Poland

Location status: Recruiting

Location contact

Wiktor Kuliczkowski, MD

CONTACT

[email protected]

+ 48 603707093

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. mortality

    Time frame: 1 month

    all cause mortality

Secondary outcomes

  1. degree of disability

    Time frame: 3 and 6 months after index event

    Modified Rankin Scale of 3 or lower

Study contacts

Contact information is provided by the study sponsor or research team.

Wiktor Kuliczkowski, MD

CONTACT

[email protected]

+ 48 603 707 093

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Collaborators

  • Wroclaw Emergency Medical Services

Registry information

Acronym: WOHCA

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2021
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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