Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02438566
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower number of units of blood required for transfusion.', 'timeFrame': '2 Years', 'description': 'Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.'}], 'secondaryOutcomes': [{'measure': 'Lower incidences of patients requiring blood transfusion.', 'timeFrame': '2 Years', 'description': 'Lower incidences of patients requiring blood transfusion in the OR, or post-operatively.'}, {'measure': 'Lower Blood Loss in Patients', 'timeFrame': 'Hospital Stay: 1-3 days.', 'description': 'Lower amounts of blood loss in patients during in surgery, and post-operatively.'}, {'measure': 'Length of Stay', 'timeFrame': '1-3 Days', 'description': 'Potential for a shorter length of hospital stay for post-surgical patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tranexamic Acid', 'Blood Loss', 'Total Hip Replacement', 'Bilateral Knee Replacement'], 'conditions': ['Osteoarthritis', 'Blood Loss, Surgical', 'Blood Loss, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.', 'detailedDescription': 'The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form.to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein. Tranexamic acid is a medicine that reduces blood loss and reduces the need for blood transfusions in surgery. This drug is not experimental and has been used widely to treat patients in many settings, including orthopedic procedures, to reduce bleeding. This medication is now part of the standard of care at many centers in the U.S. and around the world. Orthopedic procedures have used iv tranexamic acid more often, but there are reasons to believe that the oral form may be at least equivalent and perhaps better at lower cost to the health care system. No other study has yet performed a systematic comparison to answer the question.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.\n* You must be healthy enough to undergo joint replacement surgery.\n* You must be able to understand and sign an informed consent.\n* You must be at least 18 years of age.\n\nExclusion Criteria:\n\n* You cannot be under 18 years of age.\n* You cannot be undergoing revision hip or revision bilateral knee replacement surgery.\n* You cannot be part of this study if you are allergic to the medication\n* You cannot participate if you are on hemodialysis,\n* You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.\n* You will also be excluded if you have ever had a blood clot (deep vein thrombosis (DVT), pulmonary embolism (PE)).\n* You will also be excluded if you have ever had a cerebral or subarachnoid hemorrhage (brain bleeding), or stroke (cerebral vascular accident or transient ischemic attack).\n* If you are on estrogen-containing medication (hormone replacement therapy or oral contraceptive) within 7 days of surgery, you cannot take part in this study.'}, 'identificationModule': {'nctId': 'NCT02438566', 'briefTitle': 'Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The New England Baptist Hospital'}, 'officialTitle': 'Non-inferiority Trial of Oral Tranexamic Acid (OTA) vs. Intravenous Tranexamic Acid (IVTA) to Prevent Blood Loss in Joint Replacement Surgery', 'orgStudyIdInfo': {'id': '654455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Tranexamic Acid (OTA)', 'description': 'Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.', 'interventionNames': ['Drug: Tranexamic Acid (Oral)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Tranexamic Acid (IVTA)', 'description': 'Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.', 'interventionNames': ['Drug: Tranexamic Acid (Intravenous)']}], 'interventions': [{'name': 'Tranexamic Acid (Oral)', 'type': 'DRUG', 'otherNames': ['trans-4-(aminomethyl)cyclohexanecarboxylic acid', 'Lysteda'], 'description': 'OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.', 'armGroupLabels': ['Oral Tranexamic Acid (OTA)']}, {'name': 'Tranexamic Acid (Intravenous)', 'type': 'DRUG', 'otherNames': ['trans-4-(aminomethyl)cyclohexanecarboxylic acid', 'Cyklokapron'], 'description': 'IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.', 'armGroupLabels': ['Intravenous Tranexamic Acid (IVTA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Baptist Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Kenneth Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England Baptist Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New England Baptist Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kenneth Bauer', 'investigatorAffiliation': 'The New England Baptist Hospital'}}}}