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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01805466
Other study ID # GR-2009-1591573
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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