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RecruitingNCT05132387WOHCAUpdated Mar 30, 2025

Wroclaw Out-Of-Hospital Cardiac Arrest Registry

An observational study in Out-Of-Hospital Cardiac Arrest, sponsored by Wroclaw Medical University. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Wroclaw Medical University · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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%.

02

Conditions studied

  • Out-Of-Hospital Cardiac Arrest

Keywords

  • Cardiac arrest, ECMO, ECMO-CPR
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • OtherECMO 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.

06

What researchers measure

Primary outcomes

  1. mortality

    all cause mortality

    Time frame: 1 month

Secondary outcomes

  1. degree of disability

    Modified Rankin Scale of 3 or lower

    Time frame: 3 and 6 months after index event

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 32550730 ↗
  • 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. PubMed 33197396 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05132387
Lead sponsor
Wroclaw Medical University
Collaborators
Wroclaw Emergency Medical Services
Responsible party
Wiktor Kuliczkowski (Head of the Cardiac Catheterisation Laboratory, Wroclaw Medical University) — Principal investigator
First posted
Nov 24, 2021
Start date
Oct 25, 2021
Primary completion
Oct 31, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Mar 30, 2025

Study contacts

Wiktor Kuliczkowski, MD
Contact
wiktor.kuliczkowski@umw.edu.pl
+ 48 603 707 093
Wiktor Kuliczkowski, MD
principal investigator · Wroclaw Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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