[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659719":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":52,"studyPopulation":41,"armGroups":53,"interventions":71,"overallOfficials":41,"centralContacts":83,"locations":89,"responsibleParty":106,"collaborators":41,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":41,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":92,"whyStopped":41,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Military Hospital of Tunis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Peak Systolic Velocity (PSV) of Major Lower-Limb Veins","Peak systolic velocity (PSV) of major lower-limb veins measured by duplex Doppler ultrasound and compared between participants receiving apixaban twice daily, rivaroxaban once daily, or LMWH.","Within 28 days after total knee arthroplasty",[14,18,21,24,27,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Time-Averaged Mean Velocity (TAMEAN)","TAMEAN of major lower-limb veins measured by Doppler ultrasound.","Within 28 days after surgery",{"measure":19,"description":20,"timeFrame":17},"Venous Flow Volume","Venous flow volume measured by Doppler ultrasound.",{"measure":22,"description":23,"timeFrame":17},"Respiratory Phasicity","Assessment of respiratory phasicity of the common femoral and popliteal veins.",{"measure":25,"description":26,"timeFrame":17},"Distal Augmentation","Assessment of distal venous flow augmentation by Doppler ultrasound.",{"measure":28,"description":29,"timeFrame":17},"Visible Intraluminal Sludging","Assessment of visible intraluminal blood flow sludging in the assessed veins.",{"measure":31,"description":32,"timeFrame":33},"Postoperative Rehabilitation","Assessment of immobilization level, articular stiffness, and reduced range of motion.","Days 7, 15, 21, and 28",{"measure":35,"description":36,"timeFrame":37},"Postoperative Complications","Assessment of clinically relevant bleeding, anticoagulation side effects or overdose, suspected VTE, return to the operating room, and infections.","During the 28-day follow-up",{"measure":39,"description":40,"timeFrame":37},"Cardiovascular Complications","Assessment of cardiovascular complications occurring during the postoperative period.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of three parallel thromboprophylaxis groups following primary total knee arthroplasty: rivaroxaban 10 mg once daily, apixaban 2.5 mg twice daily, or LMWH once daily. Participants will be followed for 28 days, with Doppler ultrasound assessments performed at baseline and on Days 7, 15, 21, and 28.","PREVENTION",{"masking":48,"maskingDescription":49,"whoMasked":50},"SINGLE","The Doppler specialist performing the ultrasound assessments will be blinded to the participant's anticoagulation regimen.",[51],"OUTCOMES_ASSESSOR","Total knee arthroplasty is associated with a substantial risk of venous thromboembolism, and pharmacological thromboprophylaxis is routinely used after surgery. This study aims to compare three thromboprophylaxis strategies and their effects on postoperative venous hemodynamics following primary total knee arthroplasty.\n\nEligible adults undergoing elective primary unilateral total knee arthroplasty will be enrolled after providing written informed consent. Participants will be randomly assigned to one of three treatment groups: apixaban 2.5 mg twice daily, rivaroxaban 10 mg once daily, or weight-adjusted enoxaparin 40-60 mg once daily. According to the study protocol, patients receive an initial LMWH prophylactic treatment 6 hours after surgery and subsequently receive the randomized thromboprophylaxis regimen 24 hours after surgery. Treatment is planned for 14 days.\n\nThe primary objective is to compare peak systolic velocity (PSV) in major lower-limb veins between the three thromboprophylaxis groups using duplex Doppler ultrasound during the 28-day postoperative period. Additional Doppler parameters will include time-averaged mean velocity, vessel diameter, venous flow volume, respiratory phasicity, distal augmentation, and visible intraluminal sludging.\n\nSecondary assessments will include postoperative rehabilitation, level of immobilization, articular stiffness, range of motion, static and dynamic pain, postoperative bleeding, anticoagulation-related adverse effects or overdose, suspected venous thromboembolism, return to the operating room, infections, and other postoperative complications.\n\nDoppler assessments will be performed at baseline and on Days 7, 15, 21, and 28. The Doppler examiner will be blinded to the assigned anticoagulation regimen. Measurements will be performed using spectral Doppler ultrasound at the common femoral and popliteal veins.\n\nThe study plans to recruit at least 138 participants, with a minimum of 46 participants in each treatment group. The sample size was calculated to detect a 15% difference in the mean peak systolic velocity of the common femoral vein, with a two-sided alpha level of 0.05 and 80% statistical power.",[54,60,65],{"label":55,"type":56,"description":57,"interventionNames":58},"Apixaban","EXPERIMENTAL","Participants receive apixaban 2.5 mg twice daily for 14 days.",[59],"Drug: Apixaban",{"label":61,"type":56,"description":62,"interventionNames":63},"Rivaroxaban","Participants receive rivaroxaban 10 mg once daily for 14 days.",[64],"Drug: Rivaroxaban",{"label":66,"type":67,"description":68,"interventionNames":69},"LMWH","ACTIVE_COMPARATOR","Participants receive enoxaparin 40-60 mg once daily, weight-adjusted, for 14 days.",[70],"Drug: Enoxaparin (LMWH)",[72,76,79],{"type":73,"name":55,"description":74,"armGroupLabels":75,"otherNames":41},"DRUG","Apixaban 2.5 mg twice daily, starting 24 hours after surgery, for 14 days. Participants receive initial LMWH prophylaxis 6 hours after surgery before starting the assigned regimen.",[55],{"type":73,"name":61,"description":77,"armGroupLabels":78,"otherNames":41},"Rivaroxaban 10 mg once daily, starting 24 hours after surgery, for 14 days. Participants receive initial LMWH prophylaxis 6 hours after surgery before starting the assigned regimen.",[61],{"type":73,"name":80,"description":81,"armGroupLabels":82,"otherNames":41},"Enoxaparin (LMWH)","Enoxaparin 40-60 mg once daily, weight-adjusted, starting 6 hours after surgery, for 14 days.",[66],[84],{"name":85,"role":86,"phone":87,"phoneExt":41,"email":88},"Haythem Elaskri","CONTACT","54015050","haythem.elaskri@fmt.utm.tn",[90],{"facility":91,"status":92,"city":93,"state":94,"zip":41,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Principal Military Hospital of Instruction of Tunis","RECRUITING","Tunis","Tunis Governorate","Tunisia","TN",{"type":98,"coordinates":99},"Point",[100,101],10.16579,36.81897,{"lat":101,"lon":100},[104],{"name":105,"role":86,"phone":87,"phoneExt":41,"email":88},"Haythem Professor H. Elaskri",{"type":107,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100659719","comparison-of-doacs-and-lmwh-for-thromboprophylaxis-after-total-knee-arthroplasty-100659719",false,"NCT07869615","Comparison of DOACs and LMWH for Thromboprophylaxis After Total Knee Arthroplasty","Direct Oral Anticoagulants (DOACs) Once Daily (OD) Versus Direct Oral Anticoagulants (DOACs) Twice Daily (TD) Versus Low-Molecular-Weight Heparin (LMWH) for Thromboprophylaxis After Primary Total Knee Arthroplasty: A Duplex Ultrasound Assessment","DOLOTHROK","Inclusion Criteria:\n\n* Adults aged 18 years or older undergoing elective primary unilateral total knee arthroplasty.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Allergy or contraindication to the study medications.\n* Requirement for long-term therapeutic anticoagulation.\n* Requirement for antiplatelet therapy.\n* Pregnancy or lactation.\n* Active cancer or cancer treatment.\n* Documented previous venous thromboembolism in the target limb.\n* Hypercoagulable state.\n* BMI \\>40 kg\u002Fm².\n* Severe inflammatory disease.\n* Age \\>80 years.\n* Inability to comply with follow-up.\n* Incomplete data.","ALL","18 Years","80 Years",{"count":120,"type":121},138,"ESTIMATED","INTERVENTIONAL",[124],"NA","Yes. For these two fields, I would enter the following in English, based on your study protocol.\n\n1\\. Brief Summary\n\nCopy and paste:\n\nThis study aims to compare three thromboprophylaxis regimens in adults undergoing primary total knee arthroplasty: rivaroxaban 10 mg once daily, apixaban 2.5 mg twice daily, and low-molecular-weight heparin (LMWH) once daily. The study will assess venous blood flow in the lower limbs using Doppler ultrasound and determine whether blood flow differs between the three treatment groups. Participants will be randomly assigned to one of the three treatment groups and followed for 28 days after surgery. Doppler ultrasound examinations will be performed at baseline and on Days 7, 15, 21, and 28. Additional assessments will include rehabilitation progress, postoperative bleeding, suspected venous thromboembolism, cardiovascular complications, and other postoperative complications. The study is being conducted at the Department of Anesthesiology, Principal Military Hospital of Instruction of Tunis.",[127],"Venous Thromboembolism Prevention After Total Knee Arthroplasty",[129,130,131,132,61,55,133,134],"Total Knee Arthroplasty","Thromboprophylaxis","Venous Blood Flow","Doppler Ultrasound","Low-Molecular-Weight Heparin","Venous Thromboembolism","2026-10-04",{"date":137,"type":138},"2026-10-09","ACTUAL",{"date":140,"type":138},"2026-09-15",{"date":142,"type":121},"2027-04-15",{"name":5,"class":6},1]