NCT07031466

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

June 12, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

extracorporeal membrane oxygenation (ECMO)extracorporeal cardiopulmonary resuscitation (eCPR)Quality of Lifeout-of-hospital cardiac arrest (OHCA)Post-Intensive Care Syndrome (PICS)

Outcome Measures

Primary Outcomes (3)

  • Quality of Life (SF-36)

    Quality of Life in patients after eCPR will be assessed using the SF-36 questionnaire 30 days after eCPR

    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

    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

    30 days

Study Arms (2)

Retrospective eCPR group

Retrospective analysis of eCPR patients

Other: Retrospective analysis of assigned treatment

Prospective eCPR group

Prospective analysis of eCPR patients

Other: Quality of Life (SF-36)Other: Quality of Life (EQ-5D)Other: Hospital Anxiety and Depression (HADS)

Interventions

Retrospective analysis of assigned treatment will be performed

Retrospective eCPR group

The quality of life will be assessed using the SF-36 (Short-Form Health Subject Questionnaire).

Prospective eCPR group

The quality of life will be assessed using the EQ-5D (European Quality of Life Questionnaire)

Prospective eCPR group

Hospital Anxiety and Depression will be assessed using the HADS (Hospital Anxiety and Depression Scale)

Prospective eCPR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent eCPR at the University Hospital Ostrava

You may qualify if:

  • 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

You may not qualify if:

  • Language barrier
  • Acute serious mental or somatic disease making the interview not feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ostrava

Ostrava, Moravian-Silesian Region, 700 30, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrestpostintensive care syndrome

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Michaela Lišková, Bc.

    University of Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

January 1, 2022

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Locations