Out-Of-Hospital Cardiac ArrestWOHCANCT05132387
Wroclaw Out-Of-Hospital Cardiac Arrest Registry
An observational study of Out-Of-Hospital Cardiac Arrest, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- ECMO assisted CPR in out-of-hospital cardiac arrest
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 25 Oct 2021to 1 Jan 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw, Poland.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Severe body injury
- Severe active bleeding
- Drowning
- Terminal cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Wroclaw University Hostpital
Wroclaw, 50-556
Wiktor Kuliczkowski, MD, + 48 603707093, wiktor.kuliczkowski@umw.edu.pl
About this study
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%.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- ECMO assisted CPR in out-of-hospital cardiac arrest
- Keywords
- Cardiac arrest, ECMO, ECMO-CPR
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO assisted CPR in out-of-hospital cardiac arrestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Out-of-hospital cardiac arrest | Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw. Receives: Other: ECMO assisted CPR in out-of-hospital cardiac arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
all cause mortality
Measured: 1 month
Secondary outcomes (1)
degree of disability
Modified Rankin Scale of 3 or lower
Measured: 3 and 6 months after index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start25 Oct 2021
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Emergency Medical Services
- Responsible party
- Principal investigator, Wiktor Kuliczkowski, Wroclaw Medical University
- Investigators
- Wiktor Kuliczkowski, MD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132387
- Sponsor's protocol ID
- 327/2021
- Acronym
- WOHCA
- Status last verified
- Mar 2025
- First submitted
- 12 Nov 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32550730Yannopoulos 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wroclaw Out-Of-Hospital Cardiac Arrest Registry
- ClinicalTrials.gov ID
- NCT05132387
- Acronym / sponsor ID
- WOHCA / 327/2021
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Cardiac arrest, ECMO, ECMO-CPR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Wroclaw Emergency Medical Services
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of institutionalized care program of patients with 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest | – | Other: ECMO assisted CPR in out-of-hospital cardiac arrestPatients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw, Poland.
Key inclusion criteria (7 listed)
- 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™)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMO assisted CPR in out-of-hospital cardiac arrestPatients 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. | Other | Out-of-hospital cardiac arrest |
Primary outcome
mortality
Time frame: 1 month
all cause mortality
1 secondary outcome
degree of disability
Time frame: 3 and 6 months after index event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 32550730Sip 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.
- Background: PubMed 33197396Yannopoulos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wiktor Kuliczkowski, MD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wiktor Kuliczkowski, MD (+ 48 603 707 093, wiktor.kuliczkowski@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05132387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.