Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-06 @ 8:11 AM
Study NCT ID:
NCT01850394
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement
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': 'chan3s@hotmail.com', 'phone': '66-2-2011589', 'title': 'Dr. Paphon Sa-ngasoongsong', 'organization': 'Faculty of Medicine, Ramathibodi Hospital, Mahidol University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 days', 'description': 'Perioperative venous thromboembolic complications\n\n* deep vein thrombosis screened with duplex doppler ultrasound in all cases\n* pulmonary embolism diagnosed with clinical hypoxemia and confirmed with computer tomography angiogram', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Venous thromboembolic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perioperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'OG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'OG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}], 'classes': [{'title': 'Drainage blood loss', 'categories': [{'measurements': [{'value': '546.9', 'spread': '273.0', 'groupId': 'OG000'}, {'value': '475.0', 'spread': '254.4', 'groupId': 'OG001'}, {'value': '430.2', 'spread': '224.0', 'groupId': 'OG002'}]}]}, {'title': 'Calculated total blood loss', 'categories': [{'measurements': [{'value': '329.2', 'spread': '119.4', 'groupId': 'OG000'}, {'value': '239.7', 'spread': '83.7', 'groupId': 'OG001'}, {'value': '217.2', 'spread': '86.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '180', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '300', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '150', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '200', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '5 days after surgery', 'description': '* Drainage blood loss measured by accumulating total drainage volume postoperatively\n* Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Using intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Knee Function Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'OG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'OG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}], 'classes': [{'title': 'Knee Society Knee score at 1 year', 'categories': [{'measurements': [{'value': '148.9', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '151.2', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '150.9', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': 'WOMAC score at 1 year', 'categories': [{'measurements': [{'value': '15.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '7.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '140', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 year after surgery', 'description': "Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.\n\n1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.\n\n 1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better.\n2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Using intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Patients Required Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'OG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'OG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'postoperative period (5 days after surgery)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Having Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'OG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'OG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}], 'classes': [{'title': 'Re-clamp incidence', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Re-dressing incidence', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Venous thromboembolic complication', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Congestive heart failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'postoperative 1-year period', 'description': 'Postoperative complications were measured as an incidence of the following complications;\n\n* wound hematoma\n* surgical site infection\n* systemic infection\n* deep vein thrombosis\n* pulmonary embolism\n* knee stiffness requiring manipulation\n* medical complication such as myocardial infarction, congestive hear failure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Using Intention-to-treat analysis'}, {'type': 'PRIMARY', 'title': 'Total Hemoglobin Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'OG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'OG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days after surgery', 'description': 'Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Use intention-to-treat analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'FG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'FG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patients, who planned to undergo primary total knee replacement, were recruited from medical clinics before setting the operative schedule between 2009 and 2010.', 'preAssignmentDetails': 'Seventeen patients were excluded that including refusal to participate (4 patients), serum creatinine more than 2.0 mg% (4 patients), rheumatoid arthritis (4 patients), abnormal coagulogram (3 patients), and history of stroke (2 patients)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'physiologic saline 25 ml\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group'}, {'id': 'BG001', 'title': 'TXA-250 Group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'BG002', 'title': 'TXA-500 Group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid\n\nPhysiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group\n\nTranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '67.6', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '68.1', 'spread': '6.2', 'groupId': 'BG002'}, {'value': '67.3', 'spread': '7.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}], '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': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-24', 'studyFirstSubmitDate': '2013-05-02', 'resultsFirstSubmitDate': '2013-05-09', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-24', 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative Blood Loss', 'timeFrame': '5 days after surgery', 'description': '* Drainage blood loss measured by accumulating total drainage volume postoperatively\n* Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day'}, {'measure': 'Total Hemoglobin Loss', 'timeFrame': '5 days after surgery', 'description': 'Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day'}], 'secondaryOutcomes': [{'measure': 'Knee Function Scores', 'timeFrame': '1 year after surgery', 'description': "Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.\n\n1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.\n\n 1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better.\n2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better."}, {'measure': 'Number of Patients Required Blood Transfusion', 'timeFrame': 'postoperative period (5 days after surgery)'}, {'measure': 'Number of Patients Having Postoperative Complications', 'timeFrame': 'postoperative 1-year period', 'description': 'Postoperative complications were measured as an incidence of the following complications;\n\n* wound hematoma\n* surgical site infection\n* systemic infection\n* deep vein thrombosis\n* pulmonary embolism\n* knee stiffness requiring manipulation\n* medical complication such as myocardial infarction, congestive hear failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Osteoarthritis of Knee Nos']}, 'referencesModule': {'references': [{'pmid': '22053253', 'type': 'BACKGROUND', 'citation': 'Sa-Ngasoongsong P, Channoom T, Kawinwonggowit V, Woratanarat P, Chanplakorn P, Wibulpolprasert B, Wongsak S, Udomsubpayakul U, Wechmongkolgorn S, Lekpittaya N. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial. Orthop Rev (Pavia). 2011;3(2):e12. doi: 10.4081/or.2011.e12. Epub 2011 Jun 29.'}, {'pmid': '21253725', 'type': 'BACKGROUND', 'citation': 'Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.'}, {'pmid': '21048170', 'type': 'BACKGROUND', 'citation': 'Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.'}, {'pmid': '22419350', 'type': 'BACKGROUND', 'citation': 'Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.'}, {'pmid': '22419263', 'type': 'BACKGROUND', 'citation': 'Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15.'}, {'pmid': '22729012', 'type': 'BACKGROUND', 'citation': 'Seo JG, Moon YW, Park SH, Kim SM, Ko KR. The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1869-74. doi: 10.1007/s00167-012-2079-2. Epub 2012 Jun 24.'}, {'pmid': '24308672', 'type': 'DERIVED', 'citation': 'Sa-Ngasoongsong P, Wongsak S, Chanplakorn P, Woratanarat P, Wechmongkolgorn S, Wibulpolprasert B, Mulpruek P, Kawinwonggowit V. Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Dec 5;14:340. doi: 10.1186/1471-2474-14-340.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement\n* no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine \\< 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days\n* no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)\n\nExclusion Criteria:\n\n* incomplete data collection, for example, malfunctioned drain or accidental drain removal.'}, 'identificationModule': {'nctId': 'NCT01850394', 'briefTitle': 'Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'ID 01-53-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'physiologic saline 25 ml', 'interventionNames': ['Drug: Physiologic saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TXA-250 group', 'description': 'A total of 25-ml solution with 250-mg tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid', 'Drug: Physiologic saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TXA-500 group', 'description': 'A total of 25-ml solution with 500-mg tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid', 'Drug: Physiologic saline']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Transmin'], 'description': 'Inject tranexamic acid solution intra-articularly after fascia closure', 'armGroupLabels': ['TXA-250 group', 'TXA-500 group']}, {'name': 'Physiologic saline', 'type': 'DRUG', 'description': 'Use physiologic saline for mixing with tranexamic acid or use alone in placebo group', 'armGroupLabels': ['Control group', 'TXA-250 group', 'TXA-500 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Viroj Kawinwonggowit', 'investigatorAffiliation': 'Mahidol University'}}}}