Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-02-21 @ 9:40 PM
Study NCT ID:
NCT01064167
Status:
COMPLETED
Last Update Posted:
2011-02-03
First Post:
2010-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tranexamic Acid in Off-pump Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'guyanwang2006@163.com', 'phone': '86-10-88398377', 'title': 'Guyan Wang', 'organization': 'Cardiovascular Institute & Fuwai Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tranexamic Acid Group', 'description': 'Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.', 'otherNumAtRisk': 116, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The placebo consisted of an equivalent volume of saline solution.', 'otherNumAtRisk': 115, 'otherNumAffected': 0, 'seriousNumAtRisk': 115, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Required Allogenic Red Blood Cells Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The placebo consisted of an equivalent volume of saline solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1month postoperative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.'}, {'type': 'SECONDARY', 'title': 'Postoperative Chest Tube Drainage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid Group', 'description': 'Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The placebo consisted of an equivalent volume of saline solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '654', 'spread': '224', 'groupId': 'OG000'}, {'value': '891', 'spread': '295', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24h postoperative', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tranexamic Acid Group', 'description': 'Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The placebo consisted of an equivalent volume of saline solution.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'From February 2009 to December 2009, 378 consecutive patients in Fuwai hospital scheduled for elective OPCAB were enrolled in the study. 118 patients were excluded for randomizatin because not meeting inclusion criteria(n=29), Refused to participate(n=81),and surgery cancelled(n=8).', 'preAssignmentDetails': 'Of the 260 patients randomized, 130 were allocated to each group. 14 patients in tranexamic acid group and 15 in placebo group were withdrawn from the study for convert to on-pump surgery in course of surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tranexamic Acid Group', 'description': 'Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The placebo consisted of an equivalent volume of saline solution.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '60', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-11', 'studyFirstSubmitDate': '2010-02-04', 'resultsFirstSubmitDate': '2010-08-30', 'studyFirstSubmitQcDate': '2010-02-05', 'lastUpdatePostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-11', 'studyFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Required Allogenic Red Blood Cells Transfusion', 'timeFrame': '1month postoperative'}], 'secondaryOutcomes': [{'measure': 'Postoperative Chest Tube Drainage', 'timeFrame': '24h postoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tranexamic Acid', 'off-pump coronary Artery Bypass'], 'conditions': ['Off Pump Coronary Artery Bypass Surgery']}, 'referencesModule': {'references': [{'pmid': '21737704', 'type': 'DERIVED', 'citation': 'Wang G, Xie G, Jiang T, Wang Y, Wang W, Ji H, Liu M, Chen L, Li L. Tranexamic acid reduces blood loss after off-pump coronary surgery: a prospective, randomized, double-blind, placebo-controlled study. Anesth Analg. 2012 Aug;115(2):239-43. doi: 10.1213/ANE.0b013e3182264a11. Epub 2011 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.', 'detailedDescription': 'Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.\n\nTranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for elective offpump coronary artery bypass surgery\n\nExclusion Criteria:\n\n* A history of bleeding disorders\n* Active chronic hepatitis or cirrhosis\n* Chronic renal insufficiency (serum creatinine \\> 2 mg/dL)\n* Preoperative anemia (Hb \\< 10 g/dL)\n* Previous cardiac surgery\n* Myocardial infarction \\< 7 days before surgery'}, 'identificationModule': {'nctId': 'NCT01064167', 'acronym': 'TAOPCAB', 'briefTitle': 'Tranexamic Acid in Off-pump Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'FWMZ013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid group', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Drug: Tranexamic Acid']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': 'In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.', 'armGroupLabels': ['Control group', 'Tranexamic Acid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'country': 'China', 'facility': 'Cardiovascular Institute and Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Lihuan Li, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lihuan Li/Professor & Chief', 'oldOrganization': 'Dep. of anesthesiology, Cardiovascular Institute and Fuwai Hospital, CAMS and PUMC'}}}}