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

IRCCS San Raffaele Roma

Status: Completed

Conditions: C.Surgical Procedure; Cardiac

Treatments: Device: Conventional CPB; Device: EVADO

Study type: Interventional

Funder types: Other

Identifiers

NCT01805466

GR-2009-1591573

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

EVADO

Experimental group

Description:

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.

Treatment:

Device: EVADO

Conventional CPB

Active Comparator group

Description:

conventional cardiopulmonary by-pass (CPB) system

Treatment:

Device: Conventional CPB