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

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

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.

Study Overview

• Status: Completed
• Conditions: C.Surgical Procedure; Cardiac
• Intervention / Treatment: Device: EVADO; Device: Conventional CPB

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy
    • Anthea Hospital
  • Cotignola, Italy, 48010
    • Maria Cecilia Hospital
  • Lecce, Italy
    • Città di Lecce Hospital
  • Rapallo, Italy
    • ICLAS Rapallo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: EVADO; 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.
Active Comparator: Conventional CPB; conventional cardiopulmonary by-pass (CPB) system	Device: Conventional CPB; conventional miniature cardiopulmonary bypass technique

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Collaborators: Ettore Sansavini Health Science Foundation
• Investigators: Principal Investigator: Giuseppe Nasso, MD, IRCCS San Raffaele Pisana

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimated): March 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Extracorporeal Vacuum Assisted Device Optimised (EVADO)
• Other Study ID Numbers: GR-2009-1591573