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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Filip Burša, MD, PhD, EDEC
      • Ostrava, Moravian-Silesian Region, Czechia, 700 30
        • Recruiting
        • Emergency Medical Services, Moravian-Silesian Region
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.)
Procedure: Prehospital ECMO cannulation on scene of cardiac arrest
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.
Procedure: Transfer with ongoing mechanical chest compression to hospital followed by hospital ECMO cannulation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Ostrava

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emergency Medical Services, Moravian-Silesian Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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