Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03552705
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2018-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded RCT'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Synovial fluid IL-1', 'timeFrame': 'Day 5', 'description': 'To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation'}, {'measure': 'Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '6 months post-ACLR', 'description': "To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 6 months after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated."}], 'secondaryOutcomes': [{'measure': 'Quantitative MRI (qMRI)', 'timeFrame': '6 months post-ACLR', 'description': 'To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2\\* at 6 months after ACLR'}, {'measure': 'Quantitative MRI', 'timeFrame': '2 years post-ACLR', 'description': 'To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2\\* at 2 years after ACLR'}, {'measure': 'Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '2 years post-ACLR', 'description': "To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 2 years after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-30 years\n* within 4 days of unilateral ACL injury\n* presence of effusion/hemarthrosis.\n\nExclusion Criteria:\n\n* inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout/ pseudogout\n* systemic or acute illness requiring medications\n* concomitant knee injury aside from meniscus tear and MCL tear not requiring surgery\n* prior surgery to either knee\n* prior injury to either knee requiring crutches\n* history of thromboembolic disease\n* current use of combination hormonal contraception\n* chronic NSAID use\n* cortisone injection to either knee within the prior 3 months\n* not indicated for or unable to undergo ACLR within 3 months of injury'}, 'identificationModule': {'nctId': 'NCT03552705', 'briefTitle': 'The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA):The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients', 'orgStudyIdInfo': {'id': '46092'}, 'secondaryIdInfos': [{'id': 'CDMRP-PR171647', 'type': 'OTHER_GRANT', 'domain': 'DoD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid', 'description': '5-day course of standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '5-day course of placebo and intravenous saline during ACL reconstruction surgery', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': '5-day course of oral standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'Placebos', 'type': 'DRUG', 'description': '5-day course of oral placebo and intravenous saline during ACL reconstruction surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Hoang', 'role': 'CONTACT', 'email': 'c1hoang@stanford.edu', 'phone': '650-721-7612'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Christine L Hoang, BS', 'role': 'CONTACT', 'email': 'c1hoang@stanford.edu', 'phone': '650-721-7612'}], 'overallOfficials': [{'name': 'Constance Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Constance R. Chu, MD', 'investigatorAffiliation': 'Stanford University'}}}}