Optimization of Transport and Use of a Mobile ECMO Team in Patients With Sudden Cardiac Arrest in the Moravian-Silesian Region

NCT07009652 | Recruiting

• 1 other identifier: CEPR-01-ECPR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the feasibility of implementing a mobile extracorporeal membrane oxygenation (ECMO) team and optimizing patient transport logistics.

Conditions

Cardiac Arrest With Successful Resuscitation; Cardiac Arrest, Cause Unspecified

Keywords

cardiac arrest; extracorporeal membrane oxygenation; out-of-hospital cardiac arrest; extracorporeal cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

• Neurological outcome after 30 days (CPC score)

  Assessment of the neurological status of patients 30 days after the event using the Cerebral Performance Category (CPC) scale, which measures the extent of neurological impairment: * CPC 1 = good neurological condition * CPC 2 = mild impairment * CPC 3-5 = serious impairment, vegetative state or death The primary endpoint of the study is the proportion of patients with a favourable neurological outcome (CPC 1-2).

  30 days

Secondary Outcomes (3)

• Time from collapse to initiation of ECMO

  Up to 2 hours

• Transport time to the ECMO centre

  Up to 2 hours

• Arrival time for the mobile ECMO team to the scene

  Up to 2 hours

Study Arms (1)

ECPR and ECMO

Patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR).

Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)

Interventions

Extracorporeal cardiopulmonary resuscitation (ECPR) PROCEDURE

Extracorporeal cardiopulmonary resuscitation (commonly known as ECPR) is a method of cardiopulmonary resuscitation (CPR) that passes the patient's blood through a machine in a process to oxygenate the blood supply.

ECPR and ECMO

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for ECPR after out-of-hospital cardiac arrest, for whom transport of the patient to an ECMO centre or deployment of an ECMO team is logistically manage-able.

You may qualify if:

• out-of-hospital cardiac arrest
• indication for ECPR

You may not qualify if:

• death at the scene of the accident
• withdrawal of the informed consent

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Emergency Medical Services, Moravian-Silesian Region: collaborator

Study Sites (2)

Emergency Medial Services, Moravian-Silesian Region

Ostrava, Moravian-Silesian Region, 70030, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nela Walachová, Mgr.

  University Hospital Ostravs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

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

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 6, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)