Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-26 @ 5:57 PM
Study NCT ID:
NCT01873768
Status:
COMPLETED
Last Update Posted:
2016-03-21
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D015119', 'term': 'Aminocaproic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000614', 'term': 'Aminocaproates'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-18', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transfusion rate', 'timeFrame': '1.5 to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tranexamic acid', '6-Aminocaproic Acid', 'Arthroplasty', 'Osteoarthritis', 'Arthritis', 'Joint Diseases', 'Musculoskeletal Diseases', 'Rheumatic Diseases', 'Antifibrinolytic Agents', 'Fibrin Modulating Agents', 'Pharmacologic Actions', 'Coagulants', 'Therapeutic Uses'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons aged 18 - 90 years who are scheduled to undergo a unilateral total knee replacement surgery\n\nExclusion Criteria:\n\n* Non-English speaking individuals\n* Individuals with a history of deep vein thrombosis or pulmonary embolism within one year\n* Individuals with a history of coagulopathy\n* Heart stent within one year\n* Pre-operative autologous blood donation\n* Unwilling or unable to take Coumadin for deep vein thrombosis (DVT) prophylaxis\n* Received nonsteroidal anti-inflammatory drug (NSAID) or platelet antiaggregant treatment within five days prior to surgery\n* Pre-operative creatinine greater than 1.5mg/dL'}, 'identificationModule': {'nctId': 'NCT01873768', 'briefTitle': 'Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Miller Orthopedic Specialists'}, 'officialTitle': 'A Randomized Controlled Trial of Tranexamic Acid and ε-Aminocaproic Acid to Reduce Blood Loss Following Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'MOS-16735'}, 'secondaryIdInfos': [{'id': 'MOS1316735', 'type': 'OTHER', 'domain': 'Miller Orthopedic Specialists'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid (TXA)', 'description': '1g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 50ml of saline will be infused over 30 minutes beginning at the time of wound closure.', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ε-Aminocaproic Acid (EACA)', 'description': '7g in 50ml of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 50ml saline will be infused over 30 minutes beginning at the time of wound closure.', 'interventionNames': ['Drug: ε-Aminocaproic Acid (EACA)']}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': '1g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 250cc of saline will be infused over 30 minutes beginning at the time of wound closure.', 'armGroupLabels': ['Tranexamic acid (TXA)']}, {'name': 'ε-Aminocaproic Acid (EACA)', 'type': 'DRUG', 'otherNames': ['Amicar'], 'description': '7g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 250cc saline will be infused over 30 minutes beginning at the time of wound closure.', 'armGroupLabels': ['ε-Aminocaproic Acid (EACA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Miller Orthopedic Specialists', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}], 'overallOfficials': [{'name': 'Clifford K Boese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miller Orthopedic Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miller Orthopedic Specialists', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHI Health Mercy Hospital', 'class': 'OTHER'}, {'name': 'Creighton University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}