C.Surgical Procedure; Cardiac Clinical Trial
— EVADOOfficial title:
A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome
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 |
Verified date | June 2023 |
Source | IRCCS San Raffaele Roma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Anthea Hospital | Bari | |
Italy | Maria Cecilia Hospital | Cotignola | |
Italy | Città di Lecce Hospital | Lecce | |
Italy | ICLAS Rapallo | Rapallo |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele Roma | Ettore Sansavini Health Science Foundation |
Italy,
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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