Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-03 @ 4:34 AM
Study NCT ID:
NCT02554305
Status:
UNKNOWN
Last Update Posted:
2015-09-18
First Post:
2015-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Fusion Versus The Affinity Oxygenation Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2015-08-09', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major adverse events', 'timeFrame': 'Participants will be followed for 30 days following the surgery', 'description': 'Number of major adverse events (including mortality) will be assessed'}], 'secondaryOutcomes': [{'measure': 'Systemic inflammatory response', 'timeFrame': 'Participants will be followed 3 days following the surgery.', 'description': "Serum markers of inflammation will be measured at 4 time points: after induction of anesthesia, immediately after termination of cardiopulmonary bypass, 3 hours, and 3 days postoperatively. : heparinized arterial (intraoperatively) or venous (postoperatively) blood samples will be collected. Bio-assay of endothelial permeability will be also done. Within each group, the change overtime will be compared to baseline. Participants' number with abnormal laboratory values in each study group will be assessed and compared with the other groups."}, {'measure': 'Number of participants with abnormal laboratory values', 'timeFrame': 'Participants will be followed for 3 days following the surgery.', 'description': "Hemoglobin and hematocrit, Platelet number and activation and Thrombin activation will be measured. Within each group, the change overtime will be compared to baseline. Participants' number with abnormal laboratory values in each study group will be assessed and compared with the other groups."}, {'measure': 'Neurological outcomes-Functional magnetic resonance imaging (MRI)', 'timeFrame': 'Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .', 'description': 'Changes in brain structure and patterns of neural activation in response to cognitive tasks will be assessed using structural and functional MRI and compared between the study groups.'}, {'measure': 'Neurological outcomes-Transcranial Doppler (TCD)', 'timeFrame': 'Participants will be followed 3 days following the surgery.', 'description': 'Changes in brain activity pattern before and after the surgery will be assessed and compared between the study groups.'}, {'measure': 'Neurological outcomes- electroencephalogram (EEG)', 'timeFrame': 'Participants will be followed 3 days following the surgery.', 'description': 'Changes in brain activity pattern before and after the surgery will be assessed and compared between the study groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['efficacy and safety of fusion Oxygenation System', 'isolated Coronary Artery Bypass Grafting', 'Bypass Grafting'], 'conditions': ['Complication of Coronary Artery Bypass Graft']}, 'descriptionModule': {'briefSummary': 'This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.', 'detailedDescription': 'In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.\n* Patients undergoing elective peripheral vascular surgical procedures under general anesthesia\n* Patients undergoing elective percutaneous coronary intervention will serve as control groups\n\nExclusion Criteria:\n\n* Emergency operations\n* Left ventricular ejection fraction less than 30%\n* CABG with concomitant procedure\n* Previous stroke or documented neurological disorder\n* High grade (\\>70%) unilateral or bilateral carotid stenosis\n* Contraindication to MRI testing.'}, 'identificationModule': {'nctId': 'NCT02554305', 'briefTitle': 'The Fusion Versus The Affinity Oxygenation Systems', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Fusion Versus The Affinity Oxygenation Systems - A Prospective Randomized Trial In Patients Undergoing Coronary Artery Bypass Grafting (CABG)', 'orgStudyIdInfo': {'id': '0033-15-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fusion oxygenation system', 'description': 'Fusion oxygenation machine will be used during the operation.', 'interventionNames': ['Device: fusion oxygenation system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Affinity oxygenation system', 'description': 'Affinity oxygenation machine will be used during the operation.', 'interventionNames': ['Device: Affinity oxygenation system']}, {'type': 'NO_INTERVENTION', 'label': 'Peripheral vascular procedure', 'description': 'No oxygenation machine will be used in this group'}, {'type': 'NO_INTERVENTION', 'label': 'percutaneous coronary intervention', 'description': 'No oxygenation machine will be used in this group'}], 'interventions': [{'name': 'fusion oxygenation system', 'type': 'DEVICE', 'description': 'The fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile.', 'armGroupLabels': ['Fusion oxygenation system']}, {'name': 'Affinity oxygenation system', 'type': 'DEVICE', 'description': 'The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries', 'armGroupLabels': ['Affinity oxygenation system']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Oz Shapira, MD', 'role': 'CONTACT', 'email': 'Ozshapira@hadassah.org.il', 'phone': '972-2-6776960'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '972- 2- 6777572'}], 'overallOfficials': [{'name': 'Oz Shapira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DIRECTOR OF THE DEPARTMENT OF CARDIOTHORACIC SURGERY', 'investigatorFullName': 'Oz Shapira', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}