Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT06882759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-14', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excessive bleeding', 'timeFrame': 'From the end of bypass to the end of postoperative day-1 (POD1)', 'description': 'Measured by the universal definition of perioperative bleeding (UDPB) scale'}], 'secondaryOutcomes': [{'measure': 'Transfusion rate', 'timeFrame': '1) From time of entry to operating room (OR) to the end of post-operative day-1 (POD1) and post-operative day-7(POD7). 2) from end of cardiopulmonary bypass (CPB) to the end of post-operative day-1 (POD1) and post-operative day-7 (POD7)', 'description': 'Incidence and amount of transfusion of allogeneic blood products and factor concentrates'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'viscoelastic testing', 'point-of-care', 'ROTEM', 'cardiopulmonary bypass', 'bleeding'], 'conditions': ['Cardiac Surgery Requiring Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the relationship of ROTEM point-of-care coagulation assay parameters with excessive bleeding and clinical outcomes in patients undergoing cardiac surgery at Toronto General Hospital. The main questions it aims to answer are: i) How well does viscoelastic testing (VET) predict the clinical outcome of excessive bleeding in cardiac surgery? ii) Which VET parameters have the greatest accuracy for identification of patients who will have excessive bleeding? iii) 3) What is the prognostic value of abnormal VET parameters with other clinical outcomes after cardiac surgery?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥ 18 years old\n* Underwent a cardiac surgical procedure with cardiopulmonary bypass\n\nExclusion Criteria:\n\n\\- Did not undergo viscoelastic testing during surgery'}, 'identificationModule': {'nctId': 'NCT06882759', 'briefTitle': 'Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '24-5983'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac surgery patients', 'description': 'Adult patients undergoing cardiac surgery on cardiopulmonary bypass at Toronto General Hospital', 'interventionNames': ['Other: No intervention (observational study)']}], 'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'This is an observational study. No intervention.', 'armGroupLabels': ['Cardiac surgery patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Keyvan Karkouti', 'role': 'CONTACT', 'email': 'keyvan.karkouti@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '8597'}, {'name': 'Deep Grewal', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Keyvan Karkouti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}