- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07374289
On Scene ECPR in Ostrava
January 28, 2026 updated by: University Hospital Ostrava
The Effectiveness of ECPR on the Scene and in Hospital for Out-of-hospital Cardi-ac Arrest (OHCA) in the Moravian-Silesian Region.
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
ECPR is a life-saving method for a selected group of patients who are refractory to standard resuscitation procedures.
With the appropriate use of ECPR, it is possible to achieve a significant improvement in survival with good neurological outcomes even in patients who would otherwise die.
The ECMO Centre Ostrava has been providing ECPR for OHCA since 2022 with cannulation in the hospital after prior transport from the scene under continuous resuscitation.
A good neurological outcome is achieved in approximately 29% of patients, even though the collapse-ECMO interval is around 75 minutes.
Shortening this interval, which is associated with improved outcomes, is possible by using a mobile team that per-forms cannulation directly on scene.
Mobile ECPR will be carried out in cooperation with the Ostrava University Hospital and the Moravian-Silesian Region Emergency Medical Service.
The primary objective is to verify the benefit of on-scene ECPR in terms of shortening the collapse-ECMO interval.
The secondary objective is to compare the outcome in the on-scene ECPR group with hospital cannulation.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiří Hynčica
- Phone Number: 2587 +42059737
- Email: jiri.hyncica@fno.cz
Study Locations
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Czechia, 708 52
- Recruiting
- University Hospital Ostrava
-
Contact:
- Jiří Hynčica
- Phone Number: 2587 +42059737
- Email: jiri.hyncica@fno.cz
-
Principal Investigator:
- Filip Burša, MD, PhD, EDEC
-
Ostrava, Moravian-Silesian Region, Czechia, 700 30
- Recruiting
- Emergency Medical Services, Moravian-Silesian Region
-
Contact:
- David Holeš, MD, PhD
- Phone Number: 1401 +42059701
- Email: zzsmsk@zzsmsk.cz
-
Principal Investigator:
- David Holeš, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Presumed cardiac aetiology of the cardiac arrest
- Witnessed collapse
- Bystander CPR
- Estimated age ≤ 70 years
- Body weight ≥15 Kg
Exclusion Criteria:
- Known terminal malignant disease
- Known terminal chronic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ECPR on scene
On-scene ECPR cannulation by mobile ECMO team according to protocol if the location of the arrest and circumstances appear to be suitable (distance from the ECMO centre, transport logistics, in an ambulance/at home, etc.)
|
ECPR (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.
|
|
Active Comparator: ECPR in hospital
Hospital ECPR cannulation at Emergency Department by ECMO team accord-ing to protocol if a on scene ECPR call-out was not indicated.
|
ECPR (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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital survival
Time Frame: 30 days after the cardiac arrest
|
Hospital survival will be assessed 30 days after the cardiac arrest
|
30 days after the cardiac arrest
|
|
ICU stay
Time Frame: Through the ICU stay, on average 12 days
|
The length of the Intensive Care Unit (ICU) stay will be assessed in days.
|
Through the ICU stay, on average 12 days
|
|
Neurologic outcomes
Time Frame: 30 days after the cardiac arrest
|
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).
|
30 days after the cardiac arrest
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collapse to ECMO interval
Time Frame: One hour
|
The interval from the collapse (cardiac arrest) to ECMO initiation will be measured in minutes.
|
One hour
|
|
Collapse to ECMO interval
Time Frame: From the collapse (cardiac arrest) to ECMO initiation
|
The interval from the collapse (cardiac arrest) to ECMO initiation will be measured in minutes.
|
From the collapse (cardiac arrest) to ECMO initiation
|
|
Long-term outcome - Survival
Time Frame: 6 months after the collapse
|
The long-term survival of patients will be assessed 6 months after the collapse.
|
6 months after the collapse
|
|
Long-term outcome - Quality of Life
Time Frame: 6 months after the collapse
|
Long-term quality of life will be assessed 6 months after the collapse using standardised tools (questionnaires).
|
6 months after the collapse
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Filip Burša, MD, PhD, EDEC, University Hospital Ostrava
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 30, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
January 9, 2026
First Submitted That Met QC Criteria
January 24, 2026
First Posted (Actual)
January 28, 2026
Study Record Updates
Last Update Posted (Actual)
January 30, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Infarction
- Necrosis
- Myocardial Ischemia
- Myocardial Infarction
- Ischemia
- Shock
- Pathological Conditions, Signs and Symptoms
- Heart Arrest
- Shock, Cardiogenic
- Out-of-Hospital Cardiac Arrest
- Pregnancy
- Reproduction
- Reproductive Physiological Phenomena
- Reproductive and Urinary Physiological Phenomena
- Parturition
Other Study ID Numbers
- FNO-KARIM-On-Scene-ECPR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers.
The data may be provided 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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