Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
Study NCT ID:
NCT02094066
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2014-03-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Tranexamic Acid for Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemorrhage', 'timeFrame': 'intraoperative', 'description': 'the amount of bleeding in aspirator and sponges'}], 'secondaryOutcomes': [{'measure': 'erythrocyte transfusion', 'timeFrame': 'intraoperative and postoperative 3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'total hip arthroplasty'], 'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.', 'detailedDescription': 'Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 2-3\n* 18-75 age\n* total hip arthroplasty surgery\n* regional anesthesia\n\nExclusion Criteria:\n\n* allergies to drug\n* liver and kidney failure\n* ischemic heart disease\n* coagulopathy'}, 'identificationModule': {'nctId': 'NCT02094066', 'briefTitle': 'The Effect of Tranexamic Acid for Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '2012/683'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tranexamic acid', 'description': 'preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes', 'interventionNames': ['Drug: tranexamic acid']}, {'type': 'SHAM_COMPARATOR', 'label': 'serum physiologic', 'description': 'preoperative 100 cc serum physiologic', 'interventionNames': ['Drug: serum physiologic']}], 'interventions': [{'name': 'tranexamic acid', 'type': 'DRUG', 'otherNames': ['lysteda'], 'description': 'preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes', 'armGroupLabels': ['tranexamic acid']}, {'name': 'serum physiologic', 'type': 'DRUG', 'description': 'preoperative 100 cc ıv serum physiologic', 'armGroupLabels': ['serum physiologic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'seher orbay yasli, resident', 'role': 'CONTACT', 'email': 'sehersin81@hotmail.com', 'phone': '+905052401933'}, {'name': 'zeynep tosun, prof', 'role': 'CONTACT', 'email': 'zeynep@erciyes.edu.tr', 'phone': '+905326640648'}], 'facility': 'Erciyes univercity medicine faculty', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'seher orbay yasli, resident', 'role': 'CONTACT', 'email': 'sehersin81@hotmail.com', 'phone': '+905052401933'}, {'name': 'zeynep tosun, prof', 'role': 'CONTACT', 'email': 'zeynep@erciyes.edu.tr', 'phone': '+905326640648'}], 'overallOfficials': [{'name': 'seher orbay yasli, resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erciyes university medicine faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'seher orbay yasli', 'investigatorAffiliation': 'TC Erciyes University'}}}}