Status:
COMPLETED
Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)
Lead Sponsor:
IRCCS San Raffaele Roma
Collaborating Sponsors:
Ettore Sansavini Health Science Foundation
Conditions:
C.Surgical Procedure; Cardiac
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
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 experien...
Eligibility Criteria
Inclusion
- 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
- Severe renal or liver failure
- Uncompensated diabetes
- Autoimmune disease requiring immunosuppressant therapy
- Coagulation disorders
- Emergent or redo surgery
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01805466
Start Date
October 1 2012
End Date
July 1 2013
Last Update
June 22 2023
Active Locations (4)
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1
Anthea Hospital
Bari, Italy
2
Maria Cecilia Hospital
Cotignola, Italy, 48010
3
Città di Lecce Hospital
Lecce, Italy
4
ICLAS Rapallo
Rapallo, Italy