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

C.Surgical Procedure; Cardiac Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01805466
Study type Interventional
Source IRCCS San Raffaele Roma
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date July 2013
View Details
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