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

C.Surgical Procedure; Cardiac Clinical Trial

— EVADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805466
• Other study ID #: GR-2009-1591573
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2023
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Intervention

Device:
• EVADO
EVADO (Extracorporeal Vacuum-Assisted Device Optimized) device enables separation of cardiotomy suction blood, which is stored in a separate reservoir, and, if re-infusion into the CPB circuit is required, this is performed only after selective filtering and by cell saver procedures. Moreover, by using a vacuum-assisted system for blood aspiration, EVADO allows complete elimination of roller pumps, therefore reducing the extent of mechanical cellular trauma. EVADO contains a phosphorylcholine-coated oxygenator, that confers superior biocompatibility. Finally, by requiring relatively limited priming volumes, it allows reducing haemodilution.
• Conventional CPB
conventional miniature cardiopulmonary bypass technique

Locations

Country	Name	City	State
Italy	Anthea Hospital	Bari
Italy	Maria Cecilia Hospital	Cotignola
Italy	Città di Lecce Hospital	Lecce
Italy	ICLAS Rapallo	Rapallo

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma	Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other pre-specified outcome measures	• Total duration of hospital admission [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks] [Designated as safety issue: Yes]	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Other pre-specified outcome measures	• Duration of ICU stay	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Other pre-specified outcome measures	• Time to extubation	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Other pre-specified outcome measures	• Total postoperative blood loss and blood transfusion volume	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Other pre-specified outcome measures	• Total hospitalization costs	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other	Other pre-specified outcome measures	• Cost-efficiency assessment	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Primary	composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period	The primary efficacy endpoint is the composite of in-hospital mortality, defined as death of any cause occurring before hospital discharge, myocardial infarction, stroke; severe renal failure; severe liver failure; severe cardio-respiratory failure; multiorgan failure; need for left ventricular support device; need for dialysis or ultrafiltration: post-operative bleeding; atrial fibrillation.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Myocardial infarction	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Stroke	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Severe renal failure (greater than 2-fold increase in creatinine levels)	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Multiorgan failure (MOF)	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Need for left ventricular support device (IABCP or similar)	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Need for dialysis or ultrafiltration	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Postoperative bleeding	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Atrial fibrillation	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Severe liver failure (greater than 2-fold increase in AST (aspartate aminotransferase), ALT (alanine aminotransferase) and y-GT (y-glutamyltransferase) levels)	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Individual components of the primary end-point	outcome parameters recorded in the postoperative period: Severe cardio-respiratory failure	participants will be followed for the duration of hospital stay, an expected average of 2 weeks