Wroclaw Out-Of-Hospital Cardiac Arrest Registry

NCT ID: NCT05132387

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-25

Study Completion Date

2028-01-01

Brief Summary

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

Detailed Description

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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%.

Conditions

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Out-Of-Hospital Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Out-of-hospital cardiac arrest

Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw.

ECMO assisted CPR in out-of-hospital cardiac arrest

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Emergency Medical Services

UNKNOWN

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wiktor Kuliczkowski

Head of the Cardiac Catheterisation Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wiktor Kuliczkowski, MD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Locations

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Wroclaw University Hostpital

Wroclaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Wiktor Kuliczkowski, MD

Role: CONTACT

+ 48 603 707 093

Facility Contacts

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Wiktor Kuliczkowski, MD

Role: primary

+ 48 603707093

References

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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.

Reference Type BACKGROUND
PMID: 32550730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33197396 (View on PubMed)

Other Identifiers

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327/2021

Identifier Type: -

Identifier Source: org_study_id

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