C.Surgical Procedure; Cardiac
Conditions
Keywords
Extracorporeal Vacuum Assisted Device Optimised (EVADO)
Brief summary
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
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.
Interventions
DEVICEEVADO
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.
DEVICEConventional CPB
conventional miniature cardiopulmonary bypass technique
Sponsors
Ettore Sansavini Health Science Foundation
IRCCS San Raffaele Roma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the primary end-point | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | outcome parameters recorded in the postoperative period: Myocardial infarction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other pre-specified outcome measures | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | • Total duration of hospital admission \[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks\] \[Designated as safety issue: Yes\] |
Countries
Italy
Outcome results
None listed