Cardiac Arrest (CA)NCT07031466
Treatment Outcome in Patients After eCPR
An observational study of Cardiac Arrest (CA), run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
This study consists of two parts - retrospective and prospective. The aim of this study is to assess the quality of life in bio-psycho-social dimensions in patients after eCPR (extracorporeal cardiopulmonary resuscitation), in relation to their neurological outcome after the end of treatment and discharge from the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA)
- What is being tested?
- Retrospective analysis of assigned treatment, Quality of Life (SF-36) and Quality of Life (EQ-5D)
- How many people
- 74 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jan 2022to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent eCPR at the University Hospital Ostrava
Who may be able to join
- Patient who underwent eCPR after OHCA at University Hospital Ostrava
- Hospitalised in the period from 1. 1. 2022 to 31. 12. 2024
- Ability to undergo an interview personally or a family member able to provide information
- Signed informed consent
Who cannot join
- Language barrier
- Acute serious mental or somatic disease making the interview not feasible
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
University of Ostrava
Ostrava, Moravian-Silesian Region, 700 30
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
This study consists of two parts - retrospective and prospective. The aim of this study is to assess the quality of life in bio-psycho-social dimensions in patients after eCPR (extracorporeal cardiopulmonary resuscitation), in relation to their neurological outcome after the end of treatment and discharge from the Ostrava University Hospital (FNO). The study will focus on patients who underwent extracorporeal membrane oxygenation (ECMO) support after out-of-hospital cardiac arrest (OHCA) in the years 2022-2024.
Read the detailed description
Retrospective study Quantitative evaluation using data analysis from documentation. Patients on ECMO after OHCA in the period 1. 1. 2022 - 31. 12. 2024 will be evaluated based on data from the documentation. Analysis of data from the documentation of selected patients will be performed, evaluating demographic data, comorbidities, duration of ECMO support, mortality, Cerebral Performance Category (CPC) score 30 days after CPR.
Prospective study Quantitative assessment using validated questionnaire tools Patients connected to ECMO after OHCA in the period 1. 1. 2022 - 31. 12. 2024, in whom a CPC score >3 was detected after the 30th day from cardiac arrest and who were discharged from the FNO. As part of patient dispensary, these patients are electively invited to the PICS outpatient clinic in the FNO Ostrava. Individual interviews (filling out questionnaires) will be performed after obtaining informed consent in the Post-Intensive Care Syndrome (PICS) outpatient clinic at the University Hospital Ostrava, or telephone interviews conducted by the attending physician.
- Conditions
- Cardiac Arrest (CA)
- Being tested
- Retrospective analysis of assigned treatment, Quality of Life (SF-36), Quality of Life (EQ-5D), Hospital Anxiety and Depression (HADS)
- Keywords
- extracorporeal membrane oxygenation (ECMO), extracorporeal cardiopulmonary resuscitation (eCPR), Quality of Life, out-of-hospital cardiac arrest (OHCA), Post-Intensive Care Syndrome (PICS)
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of assigned treatmentOther
Retrospective analysis of assigned treatment will be performed
Quality of Life (SF-36)Other
The quality of life will be assessed using the SF-36 (Short-Form Health Subject Questionnaire).
Quality of Life (EQ-5D)Other
The quality of life will be assessed using the EQ-5D (European Quality of Life Questionnaire)
Hospital Anxiety and Depression (HADS)Other
Hospital Anxiety and Depression will be assessed using the HADS (Hospital Anxiety and Depression Scale)
| Study group | Role | What they receive |
|---|---|---|
| Retrospective eCPR group | Retrospective analysis of eCPR patients Receives: Other: Retrospective analysis of assigned treatment | |
| Prospective eCPR group | Prospective analysis of eCPR patients Receives: Other: Quality of Life (SF-36); Other: Quality of Life (EQ-5D); Other: Hospital Anxiety and Depression (HADS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (SF-36)
Quality of Life in patients after eCPR will be assessed using the SF-36 questionnaire 30 days after eCPR
Measured: 30 days
Quality of Life (EQ-5D)
Quality of Life in patients after eCPR will be assessed using the EQ-5D questionnaire 30 days after eCPR
Measured: 30 days
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) in patients after eCPR will be assessed using the EQ-5D questionnaire 30 days after eCPR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jan 2022
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michaela Lišková, Bc., Principal investigator, University of Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031466
- Sponsor's protocol ID
- FNO-KARIM-eCPR
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome in Patients After eCPR
- ClinicalTrials.gov ID
- NCT07031466
- Acronym / sponsor ID
- FNO-KARIM-eCPR
- Conditions
- Cardiac Arrest (CA)
- Keywords
- extracorporeal membrane oxygenation (ECMO), extracorporeal cardiopulmonary resuscitation (eCPR), Quality of Life, out-of-hospital cardiac arrest (OHCA), Post-Intensive Care Syndrome (PICS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 22 Jun 2025 (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.
This study consists of two parts - retrospective and prospective. The aim of this study is to assess the quality of life in bio-psycho-social dimensions in patients after eCPR (extracorporeal cardiopulmonary resuscitation), in relation to their neurological outcome after the end of treatment and discharge from the Ostrava University Hospital (FNO). The study will focus on patients who underwent extracorporeal membrane oxygenation (ECMO) support after out-of-hospital cardiac arrest (OHCA) in the years 2022-2024.
Detailed description
Retrospective study Quantitative evaluation using data analysis from documentation. Patients on ECMO after OHCA in the period 1. 1. 2022 - 31. 12. 2024 will be evaluated based on data from the documentation. Analysis of data from the documentation of selected patients will be performed, evaluating demographic data, comorbidities, duration of ECMO support, mortality, Cerebral Performance Category (CPC) score 30 days after CPR.
Prospective study Quantitative assessment using validated questionnaire tools Patients connected to ECMO after OHCA in the period 1. 1. 2022 - 31. 12. 2024, in whom a CPC score >3 was detected after the 30th day from cardiac arrest and who were discharged from the FNO. As part of patient dispensary, these patients are electively invited to the PICS outpatient clinic in the FNO Ostrava. Individual interviews (filling out questionnaires) will be performed after obtaining informed consent in the Post-Intensive Care Syndrome (PICS) outpatient clinic at the University Hospital Ostrava, or telephone interviews conducted by the attending physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective eCPR group | – | Other: Retrospective analysis of assigned treatmentRetrospective analysis of eCPR patients |
| Prospective eCPR group | – | Other: Quality of Life (SF-36), Other: Quality of Life (EQ-5D), Other: Hospital Anxiety and Depression (HADS)Prospective analysis of eCPR patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent eCPR at the University Hospital Ostrava
Key inclusion criteria (4 listed)
- Patient who underwent eCPR after OHCA at University Hospital Ostrava
- Hospitalised in the period from 1. 1. 2022 to 31. 12. 2024
- Ability to undergo an interview personally or a family member able to provide information
- Signed informed consent
Key exclusion criteria (2 listed)
- Language barrier
- Acute serious mental or somatic disease making the interview not feasible
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 |
|---|---|---|
| Retrospective analysis of assigned treatmentRetrospective analysis of assigned treatment will be performed | Other | Retrospective eCPR group |
| Quality of Life (SF-36)The quality of life will be assessed using the SF-36 (Short-Form Health Subject Questionnaire). | Other | Prospective eCPR group |
| Quality of Life (EQ-5D)The quality of life will be assessed using the EQ-5D (European Quality of Life Questionnaire) | Other | Prospective eCPR group |
| Hospital Anxiety and Depression (HADS)Hospital Anxiety and Depression will be assessed using the HADS (Hospital Anxiety and Depression Scale) | Other | Prospective eCPR group |
Primary outcome
Quality of Life (SF-36)
Time frame: 30 days
Quality of Life in patients after eCPR will be assessed using the SF-36 questionnaire 30 days after eCPR
Quality of Life (EQ-5D)
Time frame: 30 days
Quality of Life in patients after eCPR will be assessed using the EQ-5D questionnaire 30 days after eCPR
Hospital Anxiety and Depression Scale (HADS)
Time frame: 30 days
Hospital Anxiety and Depression Scale (HADS) in patients after eCPR will be assessed using the EQ-5D questionnaire 30 days after eCPR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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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. This study is not recruiting at the moment.
Michaela Lišková, Bc. principal investigator
University of Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest (CA), run by University Hospital Ostrava at 2 sites in Czechia.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (SF-36) (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.