Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT02979158
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry', 'timeFrame': 'Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers', 'description': 'Included aggregometry tests: Multiplate and Rotem Platelet'}], 'secondaryOutcomes': [{'measure': 'Postoperative bleeding', 'timeFrame': 'Postoperative bleeding 24 hrs', 'description': 'Blood loss 24 hrs post surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiopulmonary Bypass', 'Platelet Disorder', 'Bleeding Disorder', 'Platelet Dysfunction Due to Drugs']}, 'referencesModule': {'references': [{'pmid': '26402229', 'type': 'BACKGROUND', 'citation': 'Olsson A, Alfredsson J, Hakansson E, Svedjeholm R, Berglund J, Berg S. Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass. Scand Cardiovasc J. 2016;50(1):58-63. doi: 10.3109/14017431.2015.1099720. Epub 2015 Oct 20.'}, {'pmid': '25566711', 'type': 'BACKGROUND', 'citation': 'Mishra PK, Thekkudan J, Sahajanandan R, Gravenor M, Lakshmanan S, Fayaz KM, Luckraz H. The role of point-of-care assessment of platelet function in predicting postoperative bleeding and transfusion requirements after coronary artery bypass grafting. Ann Card Anaesth. 2015 Jan-Mar;18(1):45-51. doi: 10.4103/0971-9784.148321.'}, {'pmid': '10494777', 'type': 'BACKGROUND', 'citation': 'Mollnes TE, Videm V, Christiansen D, Bergseth G, Riesenfeld J, Hovig T. Platelet compatibility of an artificial surface modified with functionally active heparin. Thromb Haemost. 1999 Sep;82(3):1132-6.'}]}, 'descriptionModule': {'briefSummary': 'Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding.\n\nPresent study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods.\n\nIt is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.', 'detailedDescription': 'Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.\n\nThe surgical procedure and the use of a heart-lung machine may disturb the function of platelets, why measures to protect the existing function of platelets are of prime concern.\n\nThe present study aims to compare how two types of heart-lung machine methods influence platelet function in two groups of patients.\n\nThe platelet function will be tested before, during and after surgery by the use of two independent methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery\n\nExclusion Criteria:\n\n* Abnormal coagulation verified from preoperative assessments, platelet count \\<100 000, Warfarin medication and renal insufficiency (GFR \\< 60 ml/min)'}, 'identificationModule': {'nctId': 'NCT02979158', 'briefTitle': 'Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:', 'orgStudyIdInfo': {'id': 'DAPTUMU-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPB Low Dose', 'description': 'Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s', 'interventionNames': ['Procedure: CPB Low Dose']}, {'type': 'EXPERIMENTAL', 'label': 'CPB High Dose', 'description': 'Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s', 'interventionNames': ['Procedure: CPB High Dose']}], 'interventions': [{'name': 'CPB Low Dose', 'type': 'PROCEDURE', 'description': 'Performing CPB with low dose heparin and coated equipment', 'armGroupLabels': ['CPB Low Dose']}, {'name': 'CPB High Dose', 'type': 'PROCEDURE', 'description': 'Performing CPB with high dose heparin and uncoated equipment', 'armGroupLabels': ['CPB High Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Heart Centre Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Ulf Näslund, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Publich Health and Clinical Medicin, Umeå University, Sweden'}, {'name': 'Magnus Hedström, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heart Centre Umeå University Hospital Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}