Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT00778492
Status:
UNKNOWN
Last Update Posted:
2008-10-23
First Post:
2008-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-22', 'studyFirstSubmitDate': '2008-10-22', 'studyFirstSubmitQcDate': '2008-10-22', 'lastUpdatePostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-sternotomy d/t Bleeding', 'timeFrame': 'Hospitalization Period'}], 'secondaryOutcomes': [{'measure': 'Chest tube output during first 24 hours after the surgery', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thrombelastogram', 'Microvascular bleeding', 'antiplatelet medication', 'cardiac surgery', 'consumption of blood products', 'preoperative platelet mapping derived from modified TEG', 'postoperative bleeding'], 'conditions': ['Bleeding']}, 'descriptionModule': {'briefSummary': 'Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.', 'detailedDescription': 'Study Design:\n\nProspective observational study with blinded assessment of study endpoint variables. Collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. The information will be collected from 60 patients undergoing cardiac surgery in the Department of Cardiac Surgery of Sheba Medical Center.\n\nStudy endpoints\n\n1. Primary endpoint- resternotomy for bleeding after the surgery.\n2. Secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery with the history of aspirin and/or ADP receptor antagonist for at least 7 days prior the surgery\n\nExclusion Criteria:\n\n* Emergent surgery\n* Heart transplant surgery\n* Implantation of ventricular assist devices\n* Enrollment into conflicting study'}, 'identificationModule': {'nctId': 'NCT00778492', 'briefTitle': 'Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'SHEBA-08-5119-SP-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Treatment', 'description': 'Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sergey Preisman, MD', 'role': 'CONTACT', 'email': 'sergey.preisman@sheba.health.gov.il', 'phone': '052-6667205'}, {'name': 'Sergey Preisman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Sergey Preisman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'Alexander Kogan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Sergey Preisman, MD', 'oldOrganization': 'Sheba Medical Center'}}}}