EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications

January 10, 2022 updated by: Eurosets S.r.l.

A Prospective Single Center Study to Evaluate Safety and Efficacy of the EUROSETS Extracorporeal Membrane Oxygenation ECMOLIFE SYSTEM in Clinical Extracorporeal Life Support Applications EUROSETS ECMO STUDY

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevalence of post-cardiotomy extracorporeal life support (PC-ECLS) varies between 0.6% and 3.6% of all cardiac surgical cases and represents one of the most common applications of ECLS. While a majority of patients can be weaned from cardiopulmonary bypass using inotropic and vasoactive medication, some experience refractory cardiac and/or pulmonary dysfunction requiring prolonged postoperative mechanical circulatory support. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support is a respected therapeutic option for short-term mechanical circulatory support in these critically ill patients. Indications for PC-ECLS usually include intra-operative failure to wean from cardiopulmonary bypass due to perioperative left, right or biventricular failure, or refractory cardiogenic shock/cardiac arrest in the postoperative period. While ECLS can be a life-saving therapy, it is characterized by a high mortality and morbidity due to neurologic and vascular complications amongst others.

Recently published studies reported that long-term prognosis of in-hospital survivors after ECMO support following cardiovascular surgery remains unsatisfactory, however, patients who survive have the chance to make a full recovery despite a very unfavorable prognosis without VA-ECMO. Predisposing risk factors influencing long-term survival are not fully known, however this knowledge is necessary for adequate patient selection and comprehensive decision-making prior to ECMO implantation in order to identify those patients who will truly benefit from ECMO support, since unrestrained use might disproportionately increase hospital costs and consume valuable resources.

Recently, the Extracorporeal Life Support Organization (ELSO) Registry reported a remarkable increase in the use of ECLS as a supportive therapy after cardiac surgery. However, a disappointing trend was observed with regards to the in-hospital survival rate, reaching only 15% in the latest period.

Despite this increase in use and new technological developments in this area, only a few comprehensive and dedicated reports about PC-ECLS have been presented. Nevertheless, PC-ECLS has represented the main indication for ECLS utilization and is characterized by specific aspects (duration and type of underlying disease, severity of comorbidities, indication and type of surgical procedure, modality of access and timing of implant, complication types and rates) when compared to other ECLS indication Cardiovascular diseases (CVD) are responsible for more than 4 million deaths in Europe per year. Thereby, CVD account for approximately 45% of mortality in Europe. Apart from medical and ethical aspects, this poses an economical disaster: annual costs of roughly 210 trillion USD. Among cardiovascular diseases, coronary heart disease alone is responsible for 1 million deaths per year. Myocardial infarction (MI) is often the initial manifestation of coronary heart disease, caused by myocardial ischemia and necrosis leading to an acute decrease of cardiac function. Clinically, patients in cardiogenic shock present hypotensive, unresponsive to intravenous fluid challenge and with clinical and laboratory signs of critical end organ malperfusion requiring pharmacologic and/or mechanical circulatory support.

Cardiogenic shock (CS) is the leading cause of death after myocardial infarction and occurs in 5-10% of all cases of MI. Trials such as SHOCK, IABP-SHOCK II and IMPRESS in Severe Shock all revealed a one-year mortality of approximately 50%, which reflects constant mortality rates over the last 20 years, in spite of the applied therapeutic strategies and devices.

The unacceptably high mortality and morbidity in CS is an unsolved clinical problem despite all available treatment options.

Protected PCI is the application of Mechanical Circulatory Support (MCS) during percutaneous coronary intervention in high-risk patients, meaning that in such cases MCS systems are implanted prophylactically despite hemodynamic stability to avoid deleterious complications. The overall patient condition and temporary impairment based on the acute situation of an underlying myocardial infarction or coronary ischemia, without a manifested cardiogenic shock, are potential reasons for a "prophylactic" use of MCS.

Due to the increasing complexity of procedures and patients, feasibility of such interventions is becoming more dependent on the availability of MCS, in order to guarantee hemodynamic support during revascularization. Safety and outcome of such high-risk PCIs can potentially be improved by the application of MCS and the onset of complications such as arrhythmias, hemodynamic instability and related complications during the procedure can be reduced.

In Patient without ROSC (return of spontaneous circulation) during CPR, reestablishment of circulation by emergent VA-ECLS implantation may be indicated, since eCPR is able to improve the outcome of patients after prolonged resuscitation and no-ROSC scenario.

In 2019, at the Medical University of Vienna 25 patients were treated with eCPR (approximately 9% of all CPR-patients), 20 of these patients after OHCA (out of hospital cardiac arrest). Five patients (20%) survived with a good neurologic outcome.

In the eCPR setting, time between circulatory arrest and its recovery by the ECMO circuit, is a major crucial and impacting factor as well. The ease of use in terms of device implantation would be of high importance in those cases in particular.

In summary, for every indication, devices used in ECLS require maximum reliability and must be able to generate adequate flow for full circulatory support and minimize blood trauma especially in the setting of prolonged support. Additionally, handling and monitoring should be non-complicated, the need for frequent patient transports (operating room - ICU - remote hospital facilities as required) should be taken into account. New devices should be evaluated considering these factors- next to assessment of outcome and device-related and unrelated ECLS complications.

Study Type

Observational

Enrollment (Anticipated)

30

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 Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna, Department of Cardiac Surgery
        • Contact:
        • Principal Investigator:
          • Dominik Wiedemann, A.Prof. PD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patients <18 years
  • Pregnant and breastfeeding women

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Device Malfunction
Time Frame: in-hospital, 30 days
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
Time Frame: in-hospital, 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Mortality
Time Frame: in-hospital, 30 days
Rate of in-hospital and 30 day mortality.
in-hospital, 30 days
Rate of Adverse Events
Time Frame: in-hospital, 30 days
Rate of in-hospital and 30 day adverse events.
in-hospital, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurosets S.r.l.

Investigators

  • Study Director: Antonio Petralia, Dott., Eurosets S.r.l.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

January 10, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ECMO Study CIP 2.0_04.05.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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