Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT01805466
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.
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.
Study:
NCT01805466
Study Brief:
Protocol Section:
NCT01805466