Rapid Prehospital ACcess to ECPR in Prague

NCT ID: NCT06789978

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2026-06-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Out of Hospital Cardiac Arrest Extracorporeal Cardiopulmonary Resuscitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm interventional study with a historical control from Prague OHCA study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Extracorporeal cardiopulmonary resuscitation (ECPR)

Intervention Type OTHER

Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

Interventions

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Extracorporeal cardiopulmonary resuscitation (ECPR)

Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital, Prague

OTHER

Sponsor Role lead

Responsible Party

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Jan Bělohlávek

MD, PhD, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General University Hospital in Prague

Prague, Czechia, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jan Belohlavek, MD, PhD

Role: CONTACT

420724371594

Daniel Rob, MD, PhD

Role: CONTACT

420721932067

Facility Contacts

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Jan Belohlavek, MD, PhD

Role: primary

+420724371594

Daniel Rob, MD, PhD

Role: backup

+420721932067

Other Identifiers

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134/23 S-IV

Identifier Type: -

Identifier Source: org_study_id

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