Rapid Prehospital ACcess to ECPR in Prague

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGeneral University Hospital, Prague

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unwitnessed cardiac arrest

Asystole

ETCO2 less than 10 mmHg upon ECPR team arrival

Known limitations of intensive care (Do Not Resuscitate - DNR status)

Trial design

Design model

Single group

Treatments tested in this trial

  • Extracorporeal cardiopulmonary resuscitation (ECPR)

    Other intervention

    Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Prehospital extracorporeal cardiopulmonary resuscitation (ECPR)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time from collapse to ECPR

Time from collapse to start of VA ECMO flow

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

Secondary outcomes

1

All cause survival at 30-days

Kaplan Meier analysis, log-rank test

Time frame
30-days
2

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.

Time frame
30-days

Other outcomes

1

Major bleeding

Major bleeding, TIMI classification

Time frame
30-days
2

Vascular complications

Vascular complications including disections, pseudoaneurysm, closure, thrombus

Time frame
30-days
3

Infectious complications

Local groin infection requiring treatment or sepsis requiring treatment

Time frame
30-days

Sponsors and contacts

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