Treatment Outcome in Patients After eCPR | NCT07031466

Studies
Treatment Outcome in Patients After eCPR

NCT07031466

Sponsor

University Hospital Ostrava

Status

Completed

Last Update Posted

Dec 5, 2025Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Cardiac Arrest (CA)

Interventions

Retrospective analysis of assigned treatment
Quality of Life (SF-36)
Quality of Life (EQ-5D)
Hospital Anxiety and Depression (HADS)

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Nov 30, 2025Actual

Completion Date

Nov 30, 2025Actual

First Submitted Date

Jun 12, 2025

First Submission Date that Met QC Criteria

Jun 12, 2025

First Posted Date

Jun 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Retrospective analysis of assigned treatment	Other	Retrospective analysis of assigned treatment will be performed	Retrospective eCPR group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent eCPR at the University Hospital Ostrava

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michaela Lišková, Bc.	University of Ostrava	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ostrava		Ostrava	Moravian-Silesian Region	700 30	Czechia
University Hospital Ostrava

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D058687	Out-of-Hospital Cardiac Arrest
C000657744	postintensive care syndrome

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011788	Quality of Life

Ancestor Terms

ID	Term
D006304	Health Status
D003710	Demography
D015991	Epidemiologic Measurements
D011634	Public Health

Browse Leaves

Not provided

Browse Branches

Not provided