Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. As secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the EVADO system on the coagulation cascade and inflammatory activation.

Detailed Description
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The present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial. Participating centres are selected based on previous experience with the use of the EVADO system. Patients elected to open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination in the participating centers will be screened. This study as secondary aim wants to confirm the results of earlier investigation by a multicentre trial conducted on a larger population of patients undergoing a wide spectrum of open heart cardiac operations and either assess a number of cost-efficacy-efficiency indicators.

Official Title
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A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome

Conditions
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C.Surgical Procedure; Cardiac

Intervention / Treatment
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* Device: EVADO
* Device: Conventional CPB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients elected to undergo open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination and fulfilling the following additional criteria: Written informed consent Age 18-85 years Exclusion Criteria: Severe renal or liver failure Uncompensated diabetes Autoimmune disease requiring immunosuppressant therapy Coagulation disorders Emergent or redo surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVADO<br>The E.V.A.D.O. system is made of the following components: The ADMIRAL oxygenator, that requires low priming volumes (, has a limited contact surface and contains an accessory independent cardiotomy reservoir, allowing separation of pericardial suction blood. The HARMONY Smart Suction System, which allows automatic regulation of a pumpless extracavity blood sucker, whose rates and pressures depend on whether suction is required for blood/air surfaces (skimming), or for fluids (pooled). Paediatric circuits with 3/8 tubing for both arterial and venous lines. | Device: EVADO<br>* EVADO (Extracorporeal Vacuum-Assisted Device Optimized) device enables separation of cardiotomy suction blood, which is stored in a separate reservoir, and, if re-infusion into the CPB circuit is required, this is performed only after selective filtering and by cell saver procedures. Moreover, by using a vacuum-assisted system for blood aspiration, EVADO allows complete elimination of roller pumps, therefore reducing the extent of mechanical cellular trauma. EVADO contains a phosphorylcholine-coated oxygenator, that confers superior biocompatibility. Finally, by requiring relatively limited priming volumes, it allows reducing haemodilution.<br>|
| Active Comparator: Conventional CPB<br>conventional cardiopulmonary by-pass (CPB) system | Device: Conventional CPB<br>* conventional miniature cardiopulmonary bypass technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period | The primary efficacy endpoint is the composite of in-hospital mortality, defined as death of any cause occurring before hospital discharge, myocardial infarction, stroke; severe renal failure; severe liver failure; severe cardio-respiratory failure; multiorgan failure; need for left ventricular support device; need for dialysis or ultrafiltration: post-operative bleeding; atrial fibrillation. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Myocardial infarction | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Stroke | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Severe renal failure (greater than 2-fold increase in creatinine levels) | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Multiorgan failure (MOF) | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Need for left ventricular support device (IABCP or similar) | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Need for dialysis or ultrafiltration | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Postoperative bleeding | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Atrial fibrillation | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Severe liver failure (greater than 2-fold increase in AST (aspartate aminotransferase), ALT (alanine aminotransferase) and y-GT (y-glutamyltransferase) levels) | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| Individual components of the primary end-point | outcome parameters recorded in the postoperative period: Severe cardio-respiratory failure | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Vacuum Assisted Device Optimised (EVADO)