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Recruiting NCT07374289

On Scene ECPR in Ostrava

No phase Interventional Cardiac Arrest (CA) Cardiogenic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prehospital ECMO cannulation on scene of cardiac arrest, Transfer with ongoing mechanical chest compression to hospital followed by hospital ECMO cannulation.
Who it may be relevant to
Registry conditions: Cardiac Arrest (CA), Cardiogenic Shock. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effectiveness of ECPR on the Scene and in Hospital for Out-of-hospital Cardi-ac Arrest (OHCA) in the Moravian-Silesian Region.

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Hospital survival [Time frame: 30 days after the cardiac arrest]
  • ICU stay [Time frame: Through the ICU stay, on average 12 days]
  • Neurologic outcomes [Time frame: 30 days after the cardiac arrest]
Secondary outcome measures (4)
  • Collapse to ECMO interval [Time frame: One hour]
  • Collapse to ECMO interval [Time frame: From the collapse (cardiac arrest) to ECMO initiation]
  • Long-term outcome - Survival [Time frame: 6 months after the collapse]
  • Long-term outcome - Quality of Life [Time frame: 6 months after the collapse]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 2 centers
  • Emergency Medical Services, Moravian-Silesian Region — Ostrava
  • University Hospital Ostrava — Ostrava

Identifiers

NCT: NCT07374289 · FNO-KARIM-On-Scene-ECPR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗