Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-09 @ 11:49 AM
Study NCT ID:
NCT05956769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D013916', 'term': 'Thrombelastography'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-29', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRT maximal amplitude', 'timeFrame': '24 hours', 'description': 'maximal amplitude of CRT test'}], 'secondaryOutcomes': [{'measure': 'CK reaction time', 'timeFrame': '24 hours', 'description': 'r-time of CRT test'}, {'measure': 'CK alpha angle', 'timeFrame': '24 hours', 'description': 'alpha angle of CRT test'}, {'measure': 'CRT maximal lysis', 'timeFrame': '24 hours', 'description': 'maximal lysis of CRT test'}, {'measure': 'CFF maximal amplitude', 'timeFrame': '24 hours', 'description': 'maximal amplitude of CFF test'}, {'measure': 'Hemoglobin', 'timeFrame': '6 hours', 'description': 'the lowest hemoglobin value before transfusion'}, {'measure': 'packed RBC', 'timeFrame': '6 hours', 'description': 'transfused fresh frozen plasma'}, {'measure': 'fresh frozen plasma', 'timeFrame': '6 hours', 'description': 'transfused fresh frozen plasma'}, {'measure': 'cryoprecipitate', 'timeFrame': '6 hours', 'description': 'transfused cryoprecipitate'}, {'measure': 'platelet', 'timeFrame': '6 hours', 'description': 'transfused platelet (apheresis) or platelet concentrate'}, {'measure': 'seizure', 'timeFrame': '48 hours', 'description': 'postoperative incidence of seizure'}, {'measure': 'thromboembolism', 'timeFrame': '48 hours', 'description': 'preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction'}, {'measure': 'postoperative bleeding', 'timeFrame': '48 hours', 'description': 'bleeding from surgical drain'}, {'measure': 're-operation', 'timeFrame': '48 hours', 'description': 're-operation due to postoperative bleeding'}, {'measure': 'intraoperative bleeding', 'timeFrame': '4 hours', 'description': 'amount of intraoperative bleeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis of Hip']}, 'descriptionModule': {'briefSummary': "The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria patients undergoing following surgery\n\n\\- total hip arthroplasty\n\nExclusion Criteria:\n\n* pregnancy\n* refusal of allogenic blood transfusion\n* taking thrombin\n* history of thromboembolic and familial hypercoagulability disease\n* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)\n* hypersensitive to TXA\n* histroy of convulsion or epilepsy\n* taking hemodialysis\n* history of Heparin-induced thrombocytopenia'}, 'identificationModule': {'nctId': 'NCT05956769', 'briefTitle': 'Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery', 'orgStudyIdInfo': {'id': 'HI22C195200-1-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empirical 2: TXA administration', 'description': 'Tranexamic acid administration, regardless of the result of TEG6.', 'interventionNames': ['Drug: Tranexamic Acid', 'Diagnostic Test: thromboelastography']}, {'type': 'EXPERIMENTAL', 'label': 'Goal-directed 1: Placebo administration', 'description': 'Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 \\< 3% or MA \\> 54 mm in CRT of TEG6', 'interventionNames': ['Diagnostic Test: thromboelastography', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Goal-directed 2: TXA administration', 'description': 'Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30\\> 3% or MA\\<54 mm in CRT of TEG6', 'interventionNames': ['Drug: Tranexamic Acid', 'Diagnostic Test: thromboelastography']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': 'Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr', 'armGroupLabels': ['Empirical 2: TXA administration', 'Goal-directed 2: TXA administration']}, {'name': 'thromboelastography', 'type': 'DIAGNOSTIC_TEST', 'description': 'thromboelastography (TEG6)', 'armGroupLabels': ['Empirical 2: TXA administration', 'Goal-directed 1: Placebo administration', 'Goal-directed 2: TXA administration']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'Normal saline injection', 'armGroupLabels': ['Goal-directed 1: Placebo administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soi Lee', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}