[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618537":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":70,"collaborators":73,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":27,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":36,"enrollmentInfo":87,"targetDuration":36,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":36,"overallStatus":97,"whyStopped":36,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Chirec","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tranexamin acid","ACTIVE_COMPARATOR","This group will receive 1 dose of tranexamic acid during the induction phase, before the surgical tourniquet",[13],"Drug: Tranexamic Acid (TXA)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This arm will receive NaCl 0,9% at the same volume as calculated for 15mg\u002Fkg of tranexamic acid (before the surgical tourniquet)",[19],"Drug: Placebo (NaCl 0,9%)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tranexamic Acid (TXA)","1 dose of Tranexamic Acid 15 mg\u002Fkg",[9],[27],"TXA",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo (NaCl 0,9%)","This arm will receive NaCl 0,9% at the same volume as calculated for 15mg\u002Fkg of tranexamic acid",[15],[15],[34],{"name":35,"affiliation":36,"role":37},"Karim Touihri",null,"PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":36,"email":43},"Céline El Haddad, Anesthesia","CONTACT","+32 475466655","celineelha@outlook.fr",{"name":45,"role":41,"phone":36,"phoneExt":36,"email":46},"Touihri Clanet, Anesthesia","matthieuclanet@gmail.com",[48],{"facility":49,"status":36,"city":50,"state":36,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Chirec Delta","Brussels","1160","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],4.34878,50.85045,{"lat":58,"lon":57},[61,63,65,67,68],{"name":40,"role":41,"phone":62,"phoneExt":36,"email":43},"+32 475 46 66 55",{"name":64,"role":41,"phone":36,"phoneExt":36,"email":46},"Matthieu Clanet, Anesthesia",{"name":40,"role":66,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"name":64,"role":66,"phone":36,"phoneExt":36,"email":36},{"name":69,"role":37,"phone":36,"phoneExt":36,"email":36},"Karim Touihri, Anesthesia",{"type":37,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"matthieu clanet","Doctor",[74,76],{"name":75,"class":6},"Centre Hospitalier Universitaire Brugmann",{"name":77,"class":6},"Erasme University Hospital","100618537","phase-4-study-the-anti-inflammatory-effect-of-tranexamic-acid-when-used-in-anterior-cruciate-ligament-reconstruction-100618537",false,"NCT07332910","Study the Anti-inflammatory Effect of Tranexamic Acid When Used in Anterior Cruciate Ligament Reconstruction.","Tranexaminc Acid : Single Dose vs Placebo to Modulate Postoperative Inflammation After ACL Reconstruction : A Prospective, Randomized, Double-blind Trial","Inclusion Criteria\n\n* Adults aged 18 years or older.\n* Male or female patients scheduled for primary anterior cruciate ligament (ACL) reconstruction.\n* Surgery performed under spinal anesthesia, combined with a postoperative adductor canal block for analgesia.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Procedure performed by a single, standardized surgical team.\n* Ability to provide written informed consent.\n\nExclusion Criteria\n\n* Age under 18 years.\n* Pregnancy or breastfeeding.\n* Preoperative treatment with anticoagulant or antiplatelet therapy that cannot be safely discontinued.\n* Known coagulation disorders or history of abnormal bleeding.\n* Known hypersensitivity or allergy to tranexamic acid.\n* History of seizure disorders or epilepsy.","ALL","18 Years",{"count":88,"type":89},60,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","Tranexamic acid (TXA) is widely used in orthopedic surgery to reduce perioperative blood loss, particularly in total hip and knee arthroplasty, due to its antifibrinolytic mechanism, low cost, broad availability, and established safety profile. Its use has recently expanded to minimally invasive procedures such as knee arthroscopy and ACL reconstruction, where postoperative hemarthrosis-rather than intraoperative bleeding-is a major cause of pain, swelling, reduced range of motion, delayed rehabilitation, and impaired early recovery.\n\nRandomized trials and meta-analyses in arthroscopic ACL reconstruction show that TXA, administered intravenously, intra-articularly, or both, reduces postoperative hemarthrosis, joint swelling, drainage volume, and early pain, while improving early functional outcomes. These benefits are mainly short term, with no consistent long-term differences, and no increased risk of thromboembolic events. Evidence in arthroscopic meniscectomy is more limited but suggests modest improvements in early recovery, which may still be clinically meaningful given TXA's favorable risk-benefit profile.\n\nBeyond its antifibrinolytic effects, TXA may influence inflammatory pathways by inhibiting plasmin, which is involved in complement activation and inflammatory modulation. However, existing data are conflicting, with reports of both anti- and pro-inflammatory effects depending on surgical context and dosing. Importantly, most arthroscopy studies focus on clinical outcomes rather than systemic inflammation. To date, no study has comprehensively evaluated perioperative inflammatory responses to TXA in arthroscopic knee surgery, making this low-trauma setting an ideal model to investigate its potential inflammatory effects.",[95,96],"ACL Reconstruction","Hemarthrosis","NOT_YET_RECRUITING","2025-12-31",{"date":100,"type":101},"2026-01-12","ACTUAL",{"date":103,"type":89},"2026-01-20",{"date":105,"type":89},"2026-06-01",{"name":5,"class":6},1]