Clinical trial NCT01805466: Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)
Official title: A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: C.Surgical Procedure; Cardiac
Keywords: Extracorporeal Vacuum Assisted Device Optimised (EVADO)
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Ettore Sansavini Health Science Foundation
First posted: 2013-03-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

* Severe renal or liver failure
* Uncompensated diabetes
* Autoimmune disease requiring immunosuppressant therapy
* Coagulation disorders
* Emergent or redo surgery

Primary outcomes:
measure: composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Individual components of the primary end-point
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
measure: Other pre-specified outcome measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Other pre-specified outcome measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Other pre-specified outcome measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Other pre-specified outcome measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Other pre-specified outcome measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Other pre-specified outcome measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Locations:
city: Bari
country: Italy
facility: Anthea Hospital
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Lecce
country: Italy
facility: Città di Lecce Hospital
city: Rapallo
country: Italy
facility: ICLAS Rapallo
Study officials:
affiliation: IRCCS San Raffaele Pisana
name: Giuseppe Nasso, MD
role: PRINCIPAL_INVESTIGATOR
References: