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

NCT01805466 | Completed DMC

• 1 other identifier: GR-2009-1591573
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

C.Surgical Procedure; Cardiac

Keywords

Extracorporeal Vacuum Assisted Device Optimised (EVADO)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Individual components of the primary end-point

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Individual components of the primary end-point

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Individual components of the primary end-point

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Individual components of the primary end-point

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Individual components of the primary end-point

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Other Outcomes (6)

• Other pre-specified outcome measures

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Other pre-specified outcome measures

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Other pre-specified outcome measures

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

EVADO

EXPERIMENTAL

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

Conventional CPB

ACTIVE COMPARATOR

conventional cardiopulmonary by-pass (CPB) system

Device: Conventional CPB

Interventions

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.

EVADO

Conventional CPB DEVICE

conventional miniature cardiopulmonary bypass technique

Conventional CPB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe renal or liver failure
• Uncompensated diabetes
• Autoimmune disease requiring immunosuppressant therapy
• Coagulation disorders
• Emergent or redo surgery

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ettore Sansavini Health Science Foundation: collaborator

Study Sites (4)

Anthea Hospital

Bari, Italy

Location

Maria Cecilia Hospital

Cotignola, 48010, Italy

Location

Città di Lecce Hospital

Lecce, Italy

Location

ICLAS Rapallo

Rapallo, Italy

Location

Study Officials

• Giuseppe Nasso, MD

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 6, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

IT (4)