Rapid Prehospital ACcess to ECPR in Prague (RACE)

Prehospital Extracorporeal Cardiopulmonary Resuscitation: a Pilot Study in Prague

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

Study Overview

• Status: Recruiting
• Conditions: Out of Hospital Cardiac Arrest; Extracorporeal Cardiopulmonary Resuscitation
• Intervention / Treatment: Other: Extracorporeal cardiopulmonary resuscitation (ECPR)

Detailed Description

The aim of this pilot prospective study is to assess the feasibility and effectiveness of a prehospital extracorporeal cardiopulmonary resuscitation (ECPR) system for refractory out-of-hospital cardiac arrest (OHCA) in Prague, compared to a historical cohort of in-hospital ECPR recipients from the Prague OHCA trial.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Belohlavek, MD, PhD; Phone Number: 420724371594; Email: jan.belohlavek@vfn.cz
• Study Contact Backup: Name: Daniel Rob, MD, PhD; Phone Number: 420721932067; Email: daniel.rob@vfn.cz

Study Locations

• Czech Republic
  • Czechia
    • Prague, Czechia, Czech Republic, 12800
      • Recruiting
      • General University Hospital in Prague
      • Contact: Jan Belohlavek, MD, PhD; Phone Number: +420724371594; Email: jan.belohlavek@vfn.cz
      • Contact: Daniel Rob, MD, PhD; Phone Number: +420721932067; Email: daniel.rob@vfn.cz
      • Contact: Jan Belohlavek, MD, PhD
      • Contact: Daniel Rob, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehospital extracorporeal cardiopulmonary resuscitation (ECPR); 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); Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause survival at 30-days	Kaplan Meier analysis, log-rank test	30-days
Modified Rankin Scale at 30-days	Modified Rankin Scale (mRS) at 30 days: mRS 0-3 is considered a good outcome, and mRS 4-6 is considered a poor outcome.	30-days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	Major bleeding, TIMI classification	30-days
Vascular complications	Vascular complications including disections, pseudoaneurysm, closure, thrombus	30-days
Infectious complications	Local groin infection requiring treatment or sepsis requiring treatment	30-days

Collaborators and Investigators

• Sponsor: General University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): June 16, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac arrest; ECMO; Prehospital; ECPR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 134/23 S-IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and analyzed in this study will be available from the principal investigators upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No