On Scene ECPR in Ostrava
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital Ostrava
About this trial
On-scene extracorporeal pulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA) seems to speed up the start of extracorporeal membrane oxygenation (ECMO) and shorten low flow during cardiopulmonary resuscitation (CPR) in case of refractory cardiac arrest. The primary goal is to verify the benefit of on-scene ECPR in terms of shortening the collapse-to-ECMO interval. The secondary goal is to compare outcomes in the on-scene ECPR group with hospital cannulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presumed cardiac aetiology of the cardiac arrest
Witnessed collapse
Bystander CPR
Estimated age ≤ 70 years
Disqualifiers
Known terminal malignant disease
Known terminal chronic disease
Trial design
Design model
Parallel
Treatments tested in this trial
Prehospital ECMO cannulation on scene of cardiac arrest
Procedure/SurgeryECPR (Extracorporeal Cardiopulmonary Resuscitation) is a critical, advanced resuscitation technique using Veno-arterial Extracorporeal Membrane Oxygenation for patients in cardiac arrest where conventional CPR fails, functioning as a bridge to restore circulation and oxygenation by pumping and oxygenating blood outside the body before returning it.
Transfer with ongoing mechanical chest compression to hospital followed by hospital ECMO cannulation
Procedure/SurgeryECPR (Extracorporeal Cardiopulmonary Resuscitation) is a critical, advanced resuscitation technique using Veno-arterial Extracorporeal Membrane Oxygenation for patients in cardiac arrest where conventional CPR fails, functioning as a bridge to restore circulation and oxygenation by pumping and oxygenating blood outside the body before returning it.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: ECPR on sceneExperimental treatment 1 intervention
Group B: ECPR in hospitalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hospital survival
Hospital survival will be assessed 30 days after the cardiac arrest
Time frame
30 days after the cardiac arrest2
ICU stay
The length of the Intensive Care Unit (ICU) stay will be assessed in days.
Time frame
Through the ICU stay, on average 12 days3
Neurologic outcomes
Neurologic outcomes will be assessed in patients using the Cerebral Performance Category (CPC) score. The CPC score is a 1-to-5 scale assessing neurological outcome, most commonly after cardiac arrest, where 1 is best (normal brain function) and 5 is worst (brain death).
Time frame
30 days after the cardiac arrestSecondary outcomes
1
Collapse to ECMO interval
The interval from the collapse (cardiac arrest) to ECMO initiation will be measured in minutes.
Time frame
One hour2
Collapse to ECMO interval
The interval from the collapse (cardiac arrest) to ECMO initiation will be measured in minutes.
Time frame
From the collapse (cardiac arrest) to ECMO initiation3
Long-term outcome - Survival
The long-term survival of patients will be assessed 6 months after the collapse.
Time frame
6 months after the collapse4
Long-term outcome - Quality of Life
Long-term quality of life will be assessed 6 months after the collapse using standardised tools (questionnaires).
Time frame
6 months after the collapseSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Ostrava
Lead sponsor
Emergency Medical Services, Moravian-Silesian Region
Collaborator
Source ClinicalTrials.gov