NCT01805466

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: IRCCS San Raffaele Roma · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• C.Surgical Procedure; Cardiac

Interventions

Type	Name	Description
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.
DEVICE	Conventional CPB	conventional miniature cardiopulmonary bypass technique

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2013-03-06
• Last updated: 2023-06-22

Locations

4 sites across 1 country: Italy