A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
EVADO
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.
Intervention: EVADO (Device)
Conventional CPB
conventional cardiopulmonary by-pass (CPB) system
Intervention: Conventional CPB (Device)
Outcomes
Primary Outcomes
composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
Time Frame: 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 Outcomes
- Individual components of the primary end-point(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)