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Wroclaw Out-Of-Hospital Cardiac Arrest Registry (WOHCA)

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ClinicalTrials.gov Identifier: NCT05132387
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : January 27, 2023
Sponsor:
Collaborator:
Wroclaw Emergency Medical Services
Information provided by (Responsible Party):
Wiktor Kuliczkowski, Wroclaw Medical University

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Wroclaw Out-Of-Hospital Cardiac Arrest Registry
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. mortality [ Time Frame: 1 month ]
    all cause mortality


Secondary Outcome Measures :
  1. degree of disability [ Time Frame: 3 and 6 months after index event ]
    Modified Rankin Scale of 3 or lower


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05132387


Contacts
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Contact: Wiktor Kuliczkowski, MD + 48 603 707 093 wiktor.kuliczkowski@umw.edu.pl

Locations
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Poland
Wroclaw University Hostpital Recruiting
Wroclaw, Poland, 50-556
Contact: Wiktor Kuliczkowski, MD    + 48 603707093    wiktor.kuliczkowski@umw.edu.pl   
Sponsors and Collaborators
Wroclaw Medical University
Wroclaw Emergency Medical Services
Investigators
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Principal Investigator: Wiktor Kuliczkowski, MD Wroclaw Medical University
More Information
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Publications:

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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: November 24, 2021    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wiktor Kuliczkowski, Wroclaw Medical University:
Cardiac arrest, ECMO, ECMO-CPR
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases