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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
conventional miniature cardiopulmonary bypass technique
Anthea Hospital
Bari, Italy
Maria Cecilia Hospital
Cotignola, Italy
Città di Lecce Hospital
Lecce, Italy
ICLAS Rapallo
Rapallo, Italy
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.
Time frame: 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: Myocardial infarction
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
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outcome parameters recorded in the postoperative period: Need for left ventricular support device (IABCP or similar)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks