Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-26 @ 8:05 PM
Study NCT ID:
NCT03328832
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2017-10-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D014191', 'term': 'Tranylcypromine'}, {'id': 'C411004', 'term': 'FloSeal Matrix'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wangjw@adm.cgmh.org.tw', 'phone': '+886-7-7317123', 'title': 'Dr. Wang JW', 'phoneExt': '8003', 'organization': 'Kaohsiung Chang Gung Memorial Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Combined Topical TXA and Floseal', 'description': 'Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nFloseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 17, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Topical TXA Alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 15, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Blood Loss After Operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Topical TXA and Floseal', 'description': 'Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nFloseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}, {'id': 'OG001', 'title': 'Topical TXA Alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '678', 'spread': '203', 'groupId': 'OG000'}, {'value': '733', 'spread': '217', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.276', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'equivalence means p value \\> 0.05'}], 'paramType': 'MEAN', 'timeFrame': 'From the operation to the postoperative day 3 or 4', 'description': 'Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. 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The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}, {'id': 'OG001', 'title': 'Topical TXA Alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'equivalence means p value \\> 0.05'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the operation to the postoperative day 3 or 4', 'description': 'We will record the event of blood transfusion, and calculate the incidence of transfusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Thrombosis Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Topical TXA and Floseal', 'description': 'Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nFloseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}, {'id': 'OG001', 'title': 'Topical TXA Alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence means p value \\> 0.05'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days of the operation', 'description': 'The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combined Topical TXA and Floseal', 'description': 'Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nFloseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}, {'id': 'FG001', 'title': 'Topical TXA Alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between September 2017 and September 2018, a consecutive series of 125 patients who underwent unilateral TKA were assessed in terms of their eligibility for inclusion for this study. 35 patients were excluded based on the exclusion criteria, eight patients did not withhold antiplatelet drugs or anticoagulants 7 days before surgery, and 12 other patients declined to participate in the study. Total 70 patients were enrolled and randomly assigned into 2 groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Combined Topical TXA and Floseal', 'description': 'Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nFloseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}, {'id': 'BG001', 'title': 'Topical TXA Alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.\n\nTopical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule\n\nrivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.26', 'spread': '5.88', 'groupId': 'BG000'}, {'value': '67.47', 'spread': '4.00', 'groupId': 'BG001'}, {'value': '68.38', 'spread': '4.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '28.69', 'spread': '3.77', 'groupId': 'BG000'}, {'value': '27.44', 'spread': '4.44', 'groupId': 'BG001'}, {'value': '28.07', 'spread': '4.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Preop Hb', 'classes': [{'categories': [{'measurements': [{'value': '13.79', 'spread': '1.39', 'groupId': 'BG000'}, {'value': '13.39', 'spread': '0.85', 'groupId': 'BG001'}, {'value': '13.61', 'spread': '1.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-29', 'size': 295041, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-19T06:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2017-10-30', 'resultsFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-19', 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Blood Loss After Operation', 'timeFrame': 'From the operation to the postoperative day 3 or 4', 'description': 'Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x \\[change in Hb level / preoperative Hb level\\])x1000+volume transfused'}], 'secondaryOutcomes': [{'measure': 'Blood Transfusion Rate', 'timeFrame': 'From the operation to the postoperative day 3 or 4', 'description': 'We will record the event of blood transfusion, and calculate the incidence of transfusion'}, {'measure': 'Incidence of Thrombosis Events', 'timeFrame': 'within 30 days of the operation', 'description': 'The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombin-gelatin matrix', 'Floseal', 'Tranexamic Acid', 'Total Knee Arthroplasty'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '15067638', 'type': 'BACKGROUND', 'citation': 'Bong MR, Patel V, Chang E, Issack PS, Hebert R, Di Cesare PE. Risks associated with blood transfusion after total knee arthroplasty. J Arthroplasty. 2004 Apr;19(3):281-7. doi: 10.1016/j.arth.2003.10.013.'}, {'pmid': '9973048', 'type': 'BACKGROUND', 'citation': 'Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.'}, {'pmid': '7552610', 'type': 'BACKGROUND', 'citation': 'Goodnough LT, Verbrugge D, Marcus RE. The relationship between hematocrit, blood lost, and blood transfused in total knee replacement. Implications for postoperative blood salvage and reinfusion. Am J Knee Surg. 1995 Summer;8(3):83-7.'}, {'pmid': '11476309', 'type': 'BACKGROUND', 'citation': 'Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745.'}, {'pmid': '18067499', 'type': 'BACKGROUND', 'citation': 'Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.'}, {'pmid': '3124428', 'type': 'BACKGROUND', 'citation': 'Petaja J, Myllynen P, Myllyla G, Vahtera E. Fibrinolysis after application of a pneumatic tourniquet. Acta Chir Scand. 1987 Nov-Dec;153(11-12):647-51.'}, {'pmid': '2149215', 'type': 'BACKGROUND', 'citation': 'Kambayashi J, Sakon M, Yokota M, Shiba E, Kawasaki T, Mori T. Activation of coagulation and fibrinolysis during surgery, analyzed by molecular markers. Thromb Res. 1990 Oct 15;60(2):157-67. doi: 10.1016/0049-3848(90)90294-m.'}, {'pmid': '7772427', 'type': 'BACKGROUND', 'citation': 'Hiippala S, Strid L, Wennerstrand M, Arvela V, Mantyla S, Ylinen J, Niemela H. Tranexamic acid (Cyklokapron) reduces perioperative blood loss associated with total knee arthroplasty. Br J Anaesth. 1995 May;74(5):534-7. doi: 10.1093/bja/74.5.534.'}, {'pmid': '8636182', 'type': 'BACKGROUND', 'citation': 'Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996 May;78(3):434-40.'}, {'pmid': '11011672', 'type': 'BACKGROUND', 'citation': 'Ido K, Neo M, Asada Y, Kondo K, Morita T, Sakamoto T, Hayashi R, Kuriyama S. Reduction of blood loss using tranexamic acid in total knee and hip arthroplasties. Arch Orthop Trauma Surg. 2000;120(9):518-20. doi: 10.1007/s004029900132.'}, {'pmid': '21286886', 'type': 'BACKGROUND', 'citation': 'Lin PC, Hsu CH, Chen WS, Wang JW. Does tranexamic acid save blood in minimally invasive total knee arthroplasty? Clin Orthop Relat Res. 2011 Jul;469(7):1995-2002. doi: 10.1007/s11999-011-1789-y. Epub 2011 Feb 1.'}, {'pmid': '11939657', 'type': 'BACKGROUND', 'citation': 'Graham ID, Alvarez G, Tetroe J, McAuley L, Laupacis A. Factors influencing the adoption of blood alternatives to minimize allogeneic transfusion: the perspective of eight Ontario hospitals. Can J Surg. 2002 Apr;45(2):132-40.'}, {'pmid': '25820882', 'type': 'BACKGROUND', 'citation': 'Nishihara S, Hamada M. Does tranexamic acid alter the risk of thromboembolism after total hip arthroplasty in the absence of routine chemical thromboprophylaxis? Bone Joint J. 2015 Apr;97-B(4):458-62. doi: 10.1302/0301-620X.97B4.34656.'}, {'pmid': '26026635', 'type': 'BACKGROUND', 'citation': 'Xie J, Ma J, Kang P, Zhou Z, Shen B, Yang J, Pei F. Does tranexamic acid alter the risk of thromboembolism following primary total knee arthroplasty with sequential earlier anticoagulation? A large, single center, prospective cohort study of consecutive cases. Thromb Res. 2015 Aug;136(2):234-8. doi: 10.1016/j.thromres.2015.05.014. Epub 2015 May 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': '23541868', 'type': 'BACKGROUND', 'citation': 'Wind TC, Barfield WR, Moskal JT. 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J Arthroplasty. 2015 May;30(5):776-80. doi: 10.1016/j.arth.2014.12.001. Epub 2014 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure', 'detailedDescription': 'Total knee arthroplasty (TKA) is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Tranexamic acid (TXA), an inhibitor of fibrinolysis, was reportedly effective reducing blood loss after standard TKA. Our previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. There were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients.\n\nBesides, thrombin-based hemostatic agents, Floseal®(Baxter, Deerfield, Illinois), have been widely used in surgical procedure. Some recent studies demonstrated that topical use of Floseal® in primary TKA can reduce hemoglobin decline and calculated total blood loss after TKA. But other studies showed Floseal® does not reduce blood loss in TKA procedures.\n\nWe believe the topical use of hemostatic agent in patients with high risk of thromboembolism can avoid its systematic effect and decrease its potential perioperative risk of thromboembolic complications (arterial thrombosis, myocardial infarction and pulmonary embolism). Recently, there were some reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. The blood saving effect of topical application of TXA in primary TKA was similar with systemic administration. The mean total blood loss of topical route of TXA inTKA patients was 940-1295 ml in different reports which was still high for patients with high thromboembolic risks. However, the efficacy and safety of topical use of TXA in TKA patients with history of thromboembolic disease is still unclear. A more effective regimen for bleeding prophylaxis afer primary TKA is necessary.\n\nWe believe that combined topical applications of two hemostatic agents of different mechanisms can bring a synergistic effect in blood saving and does not increase the risk of thromboembolic disease after TKA.\n\nOur purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents in different time during surgery and the safety compared with single topical application of TKA in a primary TKA procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have advanced knee osteoarthritis are scheduled to undergo primary, unilateral elective total knee replacement surgery\n2. Age \\> 50 years and \\< 90 years\n3. Failure of medical treatment or rehabilitation.\n4. Hemoglobin \\> 11g/dl,\n5. No use of non-steroid anti-inflammatory agent one week before operation\n\nExclusion Criteria:\n\n1. Preoperative Hemoglobin ≦11 g/dl\n2. History of infection or intraarticular fracture of the affective knee\n3. Renal function deficiency (GFR \\<30 ml/min/1.73m2)which is relative contraindicated for chemical venous thromboembolism\n4. Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)\n5. History of deep vein thrombosis, ischemic heart disease or stroke\n6. Contraindications of tranexamic acid, floseal, or rivaroxaban\n7. Allergy to tranexamic acid, floseal, rivaroxaban, or the excipients\n8. History of heparin-induced thrombocytopenia (HIT)\n9. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.\n10. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria.\n11. Patients with known allergies to materials of bovine origin'}, 'identificationModule': {'nctId': 'NCT03328832', 'briefTitle': 'Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Comparison of Combined Topical Tranexamic Acid With Floseal® With Intravenous Tranexamic Acid on Blood Loss in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '201601271A0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combined topical TXA and Floseal', 'description': 'Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.', 'interventionNames': ['Drug: Topical tranexamic acid', 'Drug: Floseal®', 'Drug: rivaroxaban (10mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical TXA alone', 'description': 'Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.', 'interventionNames': ['Drug: Topical tranexamic acid', 'Drug: rivaroxaban (10mg)']}], 'interventions': [{'name': 'Topical tranexamic acid', 'type': 'DRUG', 'otherNames': ['Topical transamine'], 'description': 'Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule', 'armGroupLabels': ['Combined topical TXA and Floseal', 'Topical TXA alone']}, {'name': 'Floseal®', 'type': 'DRUG', 'otherNames': ['Thrombin-gelatin matrix'], 'description': 'Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)', 'armGroupLabels': ['Combined topical TXA and Floseal']}, {'name': 'rivaroxaban (10mg)', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.', 'armGroupLabels': ['Combined topical TXA and Floseal', 'Topical TXA alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Jun-Wen Wang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets used and analyzed in the study are available on request to the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wang Jun-Wen', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}