Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT01805466
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2013-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other pre-specified outcome measures', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': '• 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\\]'}, {'measure': 'Other pre-specified outcome measures', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': '• Duration of ICU stay'}, {'measure': 'Other pre-specified outcome measures', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': '• Time to extubation'}, {'measure': 'Other pre-specified outcome measures', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': '• Total postoperative blood loss and blood transfusion volume'}, {'measure': 'Other pre-specified outcome measures', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': '• Total hospitalization costs'}, {'measure': 'Other pre-specified outcome measures', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': '• Cost-efficiency assessment'}], 'primaryOutcomes': [{'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', 'description': '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.'}], 'secondaryOutcomes': [{'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', 'description': 'outcome parameters recorded in the postoperative period: Myocardial infarction'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nStroke'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nSevere renal failure (greater than 2-fold increase in creatinine levels)'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nMultiorgan failure (MOF)'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nNeed for left ventricular support device (IABCP or similar)'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nNeed for dialysis or ultrafiltration'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nPostoperative bleeding'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nAtrial fibrillation'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nSevere liver failure (greater than 2-fold increase in AST (aspartate aminotransferase), ALT (alanine aminotransferase) and y-GT (y-glutamyltransferase) levels)'}, {'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', 'description': 'outcome parameters recorded in the postoperative period:\n\nSevere cardio-respiratory failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Extracorporeal Vacuum Assisted Device Optimised (EVADO)'], 'conditions': ['C.Surgical Procedure; Cardiac']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial.\n\nParticipating centres are selected based on previous experience with the use of the EVADO system.\n\nPatients 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients 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:\n\n* Written informed consent\n* Age 18-85 years\n\nExclusion Criteria:\n\n* Severe renal or liver failure\n* Uncompensated diabetes\n* Autoimmune disease requiring immunosuppressant therapy\n* Coagulation disorders\n* Emergent or redo surgery'}, 'identificationModule': {'nctId': 'NCT01805466', 'acronym': 'EVADO', 'briefTitle': 'Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele Roma'}, 'officialTitle': 'A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome', 'orgStudyIdInfo': {'id': 'GR-2009-1591573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVADO', 'description': 'The E.V.A.D.O. system is made of the following components:\n\n* The ADMIRAL oxygenator, that requires low priming volumes (, has a limited contact surface and contains an accessory independent cardiotomy reservoir, allowing separation of pericardial suction blood.\n* The HARMONY Smart Suction System, which allows automatic regulation of a pumpless extracavity blood sucker, whose rates and pressures depend on whether suction is required for blood/air surfaces (skimming), or for fluids (pooled).\n* Paediatric circuits with 3/8" tubing for both arterial and venous lines.', 'interventionNames': ['Device: EVADO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional CPB', 'description': 'conventional cardiopulmonary by-pass (CPB) system', 'interventionNames': ['Device: Conventional CPB']}], 'interventions': [{'name': 'EVADO', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['EVADO']}, {'name': 'Conventional CPB', 'type': 'DEVICE', 'description': 'conventional miniature cardiopulmonary bypass technique', 'armGroupLabels': ['Conventional CPB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'country': 'Italy', 'facility': 'Anthea Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '48010', 'city': 'Cotignola', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'Città di Lecce Hospital', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Rapallo', 'country': 'Italy', 'facility': 'ICLAS Rapallo', 'geoPoint': {'lat': 44.3496, 'lon': 9.22796}}], 'overallOfficials': [{'name': 'Giuseppe Nasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele Pisana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele Roma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ettore Sansavini Health Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}