EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications

NCT05163925 | Recruiting

• 1 other identifier: ECMO Study CIP 4.0_07.03.2025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-center study designed for evaluation of safety and performance of the Conformitè Europëenne (CE)-marked EUROSETS ECMOLIFE SYSTEM, composed by: ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC) in all clinical ECLS applications (e.g. post-cardiotomy ECLS as well as application for cardiogenic shock after myocardial infarction or resulting from other etiologies, as well as ECLS application in patients under cardiopulmonary resuscitation (eCPR) and protected PCI) in 30 consecutive patients. All demographic and perioperative variables (ECMOLIFE SYSTEM -related and unrelated ECLS complications, performances of the ECMOLIFE SYSTEM) will be analyzed. Surgical techniques will be recorded. Follow-up information on survival and any adverse cardiac and cerebrovascular events will be gathered routinely by outpatient clinic and telephone calls until 30 days after ECLS initiation or hospital discharge.

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

Extracorporeal Life Support Applications

Outcome Measures

Primary Outcomes (2)

• Rate of Device Malfunction

  Rate of device malfunction of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.

  in-hospital, 30 days

• Rate of device related complications

  Rate of device related complications of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.

  in-hospital, 30 days

Secondary Outcomes (2)

• Rate of Mortality

  in-hospital, 30 days

• Rate of Adverse Events

  in-hospital, 30 days

Study Arms (1)

EUROSETS ECMOLIFE SYSTEM

Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. ECMOLIFE System is a perfusion system enabling operation and monitoring of extracorporeal circulation. ECMOLIFE System operates, powers, controls and regulates ECMOLIFE Centrifugal Pump which represents the disposable blood pump. ECMOLIFE System, when used in combination with ECMOLIFE Centrifugal Pump, is suitable for full or partial cardiac, circulatory and pulmonary support. ECMOLIFE System is composed by an active programmable console (ECMOLIFE Console), a bearing-less motor driver (ECMOLIFE Motor driver), and sensors for blood parameters detection (flow rate, pressure, temperature, SvO2 and Hb). The console is equipped with an integrated back-up which in case of primary unit failure may be operated in combination with a back-up motor driver and flowmeter (besides, the ECMOLIFE system includes an Heater cooler device).

Device: Eurosets ECMO Life System

Interventions

Eurosets ECMO Life System DEVICE

ECMOLIFE System in combination with ECMOLIFE Centrifugal Pump and ECC (extra-corporeal-circulation) Tubing Set is intended to pump blood through the extracorporeal circuit to provide extracorporeal circulation. ECMOLIFE System must be used only in combination with ECMOLIFE Centrifugal Pump. ECMOLIFE System is intended to operate in the following hospital environments: Operating Room, Catheter Laboratory, Emergency Room, Intensive Care Unit and during intra-hospital patient transportation from one to another Unit. ECMOLIFE System is intended to be used by qualified healthcare professionals specifically trained in the field of extracorporeal circulation: Perfusionists (Thoracic Cardiovascular Surgery - OR), Intensivists, ICU Nurses (ICU), Emergency physicians / Intensivists (ER), Cardiologist (CathLab).

EUROSETS ECMOLIFE SYSTEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. As the current study is a prospective study, choice of the device is based on surgeons' preference. ECLS usually is an unplanned procedure, post-hoc informed consent will be obtained in ECLS survivors before hospital discharge. However, when a patient clearly stated in the patient file he or she does not wish to participate in any trials, this will be honored. A screening log providing detailed information on inclusion or reasons for exclusion will be kept in record.

You may qualify if:

• Patients ≥18 years
• VA-ECLS application using the EUROSETS ECMOLIFE SYSTEM (e.g. cardiogenic shock, post cardiotomy low cardiac output syndrome, cardiac arrest, high risk percutaneous coronary intervention, eCPR)

You may not qualify if:

• Patients \<18 years
• Pregnant and breastfeeding women

Sponsors & Collaborators

• Eurosets S.r.l.: lead

Study Sites (1)

Medical University of Vienna, Department of Cardiac Surgery

Vienna, 1090, Austria

RECRUITING

Related Publications (21)

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Biospecimen

Retention: SAMPLES WITH DNA

Laboratory values pre-ECLS and daily during ECLS support * Hemoglobin * Hematocrit * Leukocytes * Platelets * Creatinine * BUN (Blood Urea Nitrogen) * AST (Aspartate-Aminotransferase) * ALT (Alanine-Aminotransferase) * Gamma GT (Gain of Thyroid) * LDH (Lactate Dehydrogenase) * Bilirubin * C-reactive protein * Hemolysis index * Fibrinogen * D-dimer if applicable * aPTT (activated partial Thromboplastin Time) or anti-Xa if applicable * Activated clotting time if applicable * Lactate * pH (acid base indicator) * pO2 (Oxygen partial pressure) * pCO2 (Carbon dioxide partial pressure) * SO2 (Oxygen saturation) * HCO3 (Bicarbonate) * BE (Base Excess) * SvO2 (Mixed venous oxygen saturation) if applicable

Study Officials

• Antonio Petralia, Dott.

  Eurosets S.r.l.

  STUDY DIRECTOR

Central Study Contacts

Antonio Petralia, Dott.

CONTACT

+39 0535 660370; apetralia@eurosets.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: December 20, 2021
• Study Start: January 10, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-03

Locations

AU (1)