[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03552705":3,"trial-entities:NCT03552705":105,"trial-summary:NCT03552705":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":48,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":79,"locations":81,"central_contacts":96,"overall_officials":99,"references":103,"see_also_links":104},"NCT03552705","46092","The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients","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","RECRUITING","2027-01-14","2026-01","2026-02-27","2019-08-01","Stanford University","OTHER",true,"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.",null,[19],"Anterior Cruciate Ligament Reconstruction",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},50,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Tranexamic Acid","5-day course of oral standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg\u002Fday) 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)",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Placebos","5-day course of oral placebo and intravenous saline during ACL reconstruction surgery",[38],"Placebo",[40,44],{"measure":41,"description":42,"timeFrame":43},"Synovial fluid IL-1","To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation","Day 5",{"measure":45,"description":46,"timeFrame":47},"Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)","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.","6 months post-ACLR",[49,52,56],{"measure":50,"description":51,"timeFrame":47},"Quantitative MRI (qMRI)","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":53,"description":54,"timeFrame":55},"Quantitative MRI","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","2 years post-ACLR",{"measure":45,"description":57,"timeFrame":55},"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.","ALL","18 Years","30 Years",false,{"inclusion":63,"exclusion":67,"raw_text":78},[64,65,66],"age 18-30 years","within 4 days of unilateral ACL injury","presence of effusion\u002Fhemarthrosis.",[68,69,70,71,72,73,74,75,76,77],"inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout\u002F pseudogout","systemic or acute illness requiring medications","concomitant knee injury aside from meniscus tear and MCL tear not requiring surgery","prior surgery to either knee","prior injury to either knee requiring crutches","history of thromboembolic disease","current use of combination hormonal contraception","chronic NSAID use","cortisone injection to either knee within the prior 3 months","not indicated for or unable to undergo ACLR within 3 months of injury","Inclusion Criteria:\n\n* age 18-30 years\n* within 4 days of unilateral ACL injury\n* presence of effusion\u002Fhemarthrosis.\n\nExclusion Criteria:\n\n* inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout\u002F 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",[80],"ADULT",[82],{"facility":13,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":93},"Stanford","California","94305","United States",[88],{"name":89,"role":90,"phone":91,"email":92},"Christine Hoang","CONTACT","650-721-7612","c1hoang@stanford.edu",{"lat":94,"lon":95},37.42411,-122.16608,[97],{"name":98,"role":90,"phone":91,"email":92},"Christine L Hoang, BS",[100],{"name":101,"affiliation":13,"role":102},"Constance Chu, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":15,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This interventional study plans to enroll 50 participants. It will compare Tranexamic Acid to a placebo (inactive treatment).","completed","Tranexamic Acid for ACL Injury and Joint Health","This study is looking at whether Tranexamic Acid (TXA), an FDA-approved medication, can help reduce inflammation and improve joint health after an Anterior Cruciate Ligament (ACL) injury and reconstruction surgery. Patients who tear their ACL are at high risk for developing arthritis later on. Researchers believe that TXA, by reducing bleeding and inflammation, might help prevent or delay this. You could be eligible if you are between 18 and 30 years old, had a recent ACL injury (within 4 days), and have swelling or bleeding in your knee. The study will measure inflammation levels in your joint fluid and your knee symptoms after 6 months. The current recruitment status is unclear.","Your knee symptoms will be assessed at 6 months after ACL reconstruction surgery.",111,"Participants would receive Tranexamic Acid or placebo orally for 5 days and intravenously during ACL reconstruction surgery. Your joint fluid will be measured at Day 5, and you will report on your knee symptoms at 6 months after surgery.","Not stated in the trial record.",[31],"v2"]