Rapid Prehospital ACcess to ECPR in Prague

NCT06789978 | Recruiting

• 1 other identifier: 134/23 S-IV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective pilot feasibility study of prehospital ECPR in patients with refractory OHCA

Conditions

Out of Hospital Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation

Keywords

Cardiac arrest; ECPR; ECMO; Prehospital

Outcome Measures

Primary Outcomes (1)

• Time from collapse to ECPR

  Time from collapse to start of VA ECMO flow

  Time from estimated collapse to start of VA ECMO flow (estimated range: 20-100 minutes)

Secondary Outcomes (2)

• All cause survival at 30-days

  30-days

• Modified Rankin Scale at 30-days

  30-days

Other Outcomes (3)

• Major bleeding

  30-days

• Vascular complications

  30-days

• Infectious complications

  30-days

Study Arms (1)

Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

EXPERIMENTAL

Prehospital ECPR will include all patients who enter the study and receive ECPR. The historical control group will consist of patients from the Prague OHCA study who received in-hospital ECPR and fulfilled all relevant inclusion and exclusion criteria for this study.

Other: Extracorporeal cardiopulmonary resuscitation (ECPR)

Interventions

Extracorporeal cardiopulmonary resuscitation (ECPR) OTHER

Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated age 18-70 years
• Refractory out-of-hospital cardiac arrest (3 unsuccessful defibrillations and/or at least 10 minutes of resuscitation in case of pulseless electrical activity)
• Witnessed cardiac arrest
• ECPR team available
• ECPR team alert within 20 minutes from the emergency call

You may not qualify if:

• Unwitnessed cardiac arrest
• Asystole
• ETCO2 less than 10 mmHg upon ECPR team arrival
• Known limitations of intensive care (Do Not Resuscitate - DNR status)
• Known severe neurological impairment prior to cardiac arrest (mRS 4-6)
• Suspected or known pregnancy

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital in Prague

Prague, Czechia, 12800, Czechia

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jan Belohlavek, MD, PhD

CONTACT

420724371594; jan.belohlavek@vfn.cz

Daniel Rob, MD, PhD

CONTACT

420721932067; daniel.rob@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, professor

Model Details: Single-arm interventional study with a historical control from Prague OHCA study

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 23, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)