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NCT Number: NCT06789978

Rapid Prehospital ACcess to ECPR in Prague

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

Recruiting

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Key information

Conditions

Out of Hospital Cardiac Arrest Cardiovascular Diseases Extracorporeal Cardiopulmonary Resuscitation Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General University Hospital in Prague

Prague, Czechia, 12800

Location status: Recruiting

Location contact

Daniel Rob, MD, PhD

CONTACT

[email protected]

+420721932067

Daniel Rob, MD, PhD

PRINCIPAL_INVESTIGATOR

Jan Belohlavek, MD, PhD

CONTACT

[email protected]

+420724371594

Jan Belohlavek, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal cardiopulmonary resuscitation (ECPR)

Other

Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

Primary outcomes

  1. Time from collapse to ECPR

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

    Time from collapse to start of VA ECMO flow

Secondary outcomes

  1. All cause survival at 30-days

    Time frame: 30-days

    Kaplan Meier analysis, log-rank test

  2. Modified Rankin Scale at 30-days

    Time frame: 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.

Other outcomes

  1. Major bleeding

    Time frame: 30-days

    Major bleeding, TIMI classification

  2. Vascular complications

    Time frame: 30-days

    Vascular complications including disections, pseudoaneurysm, closure, thrombus

  3. Infectious complications

    Time frame: 30-days

    Local groin infection requiring treatment or sepsis requiring treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Rob, MD, PhD

CONTACT

[email protected]

420721932067

Jan Belohlavek, MD, PhD

CONTACT

[email protected]

420724371594

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

Prehospital Extracorporeal Cardiopulmonary Resuscitation: A Pilot Study in Prague

Acronym: RACE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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