Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ettore Sansavini Health Science Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVADO | Experimental | The E.V.A.D.O. system is made of the following components:
|
|
| Conventional CPB | Active Comparator | conventional cardiopulmonary by-pass (CPB) system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVADO | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other pre-specified outcome measures | • Total duration of hospital admission [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks] [Designated as safety issue: Yes] | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Nasso, MD | IRCCS San Raffaele Pisana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anthea Hospital | Bari | Italy | ||||
| Maria Cecilia Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional CPB | Device | conventional miniature cardiopulmonary bypass technique |
|
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 |
| Other pre-specified outcome measures |
• Duration of ICU stay |
| participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Other pre-specified outcome measures | • Time to extubation | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Other pre-specified outcome measures | • Total postoperative blood loss and blood transfusion volume | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Other pre-specified outcome measures | • Total hospitalization costs | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Other pre-specified outcome measures | • Cost-efficiency assessment | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Cotignola |
| 48010 |
| Italy |
| Città di Lecce Hospital | Lecce | Italy |
| ICLAS Rapallo | Rapallo | Italy |