Clinical Trials Logo
  1. Home
  2. C.Surgical Procedure; Cardiac
  3. NCT01805466

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
See also
  Status Clinical Trial Phase
Recruiting NCT02908009 - A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery
Completed NCT01998438 - Prospective Trial of Tranexamic Acid in Cardiac Surgery Phase 4
Completed NCT02658006 - Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients N/A
Completed NCT02571920 - Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) N/A
Completed NCT02267538 - Dexmedetomidine and Delirium in Patients After Cardiac Surgery Phase 4
Completed NCT02866825 - Studying Complement Inhibition in Complex Cardiac Surgery Phase 2
Completed NCT02513862 - Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery N/A
Completed NCT02560519 - Albumin in Cardiac Surgery Phase 4
Recruiting NCT03884725 - Fibrinogen Concentrate In Children Cardiac Surgery 2 Phase 4
Recruiting NCT01879475 - Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery N/A
Completed NCT00598195 - Ketamine Pharmacokinetics in Children Having Heart Surgery N/A
Completed NCT02972684 - Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass N/A
Recruiting NCT02560285 - High-risk Patients in Cardiac Surgery Procedures: HiriSCORE N/A
Terminated NCT02793895 - Detection of Atrial Fibrillation After Cardiac Surgery N/A
Active, not recruiting NCT03343418 - Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery Phase 4
Recruiting NCT03469440 - Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery N/A
Recruiting NCT03882593 - Blood Cell Adhesion to Arterial Filters During Cardiac Surgery
Withdrawn NCT02119806 - Decreasing the Incidence of Delirium After Cardiac Surgery Phase 4
Completed NCT02831907 - Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery N/A
Recruiting NCT02745951 - HELIox CardiOPlegia Trial During Cardiac surgERy N/A