Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT03458351
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet activation measured by CD62P expression using flow cytometry', 'timeFrame': 'During 3hour after cardiopulmonary bypass initiation', 'description': 'CD62P AUC (area under the curve)'}], 'secondaryOutcomes': [{'measure': 'Platelet activation measured by CD63 expression using flow cytometry', 'timeFrame': 'During 3hour after cardiopulmonary bypass initiation', 'description': 'CD63 AUC (area under the curve)'}, {'measure': 'Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry', 'timeFrame': 'During 3hour after cardiopulmonary bypass initiation', 'description': 'MPA AUC (area under the curve)'}, {'measure': 'Platelet activation measured by PAC1 expression using flow cytometry', 'timeFrame': 'During 3hour after cardiopulmonary bypass initiation', 'description': 'PAC1 AUC (area under the curve)'}, {'measure': 'Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry', 'timeFrame': 'During 3hour after cardiopulmonary bypass initiation', 'description': 'PMP AUC (area under the curve)'}, {'measure': 'ADPtest by Multiplate® platelet function analyser', 'timeFrame': '3hour after cardiopulmonary bypass initiation', 'description': 'ADPtest AU'}, {'measure': 'ASPItest by Multiplate® platelet function analyser', 'timeFrame': '3hour after cardiopulmonary bypass initiation', 'description': 'ASPItest AU'}, {'measure': 'COLtest by Multiplate® platelet function analyser', 'timeFrame': '3hour after cardiopulmonary bypass initiation', 'description': 'COLtest AU'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet activation', 'remote ischemic preconditioning'], 'conditions': ['Platelet Dysfunction']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.', 'detailedDescription': 'Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Preoperative left ventricle ejection fraction \\< 30%, mechanical ventricular support\n* Peripheral vascular disease\n* Poorly controlled diabetes mellitus\n* NSAIDs within 3 days\n* iv heparin within 6 h\n* low molecular weight heparin within 24 h\n* platelet inhibitor within 24 h\n* known thrombocytopenia\n* End stage renal disease / hemodialysis\n* Active infection\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03458351', 'briefTitle': 'RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'RIPC_platelet activation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remote ischemic preconditioning', 'description': 'Remote ischemic conditioning after anesthesia induction\n\n\\- four cycles of 5 min of ischemia followed by 5 min of reperfusion by inflation to 200 mm Hg and deflation of a blood pressure cuff on the upper arm', 'interventionNames': ['Device: Remote ischemic preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham control', 'description': 'The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg.', 'interventionNames': ['Device: Sham control']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'DEVICE', 'description': 'Four cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated.', 'armGroupLabels': ['Remote ischemic preconditioning']}, {'name': 'Sham control', 'type': 'DEVICE', 'description': 'The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced.', 'armGroupLabels': ['Sham control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yunseok Jeon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yunseok Jeon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}