[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659378":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":37,"armGroups":38,"interventions":54,"overallOfficials":33,"centralContacts":67,"locations":73,"responsibleParty":88,"collaborators":33,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":33,"enrollmentInfo":102,"targetDuration":33,"studyType":105,"phases":33,"briefSummary":106,"conditions":107,"keywords":33,"overallStatus":76,"whyStopped":33,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Monastir","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of symptomatic venous thromboembolism (VTE)","Occurrence of objectively confirmed symptomatic venous thromboembolism, including proximal deep vein thrombosis (DVT) and\u002For pulmonary embolism (PE)","Within 45 days after enrollment",[14,17,20,24,27,30],{"measure":15,"description":16,"timeFrame":12},"Incidence of objectively confirmed distal deep vein thrombosis (DVT)","Occurrence of objectively confirmed distal DVT diagnosed by compression ultrasonography",{"measure":18,"description":19,"timeFrame":12},"Incidence of major and clinically relevant non-major bleeding","Occurrence of major bleeding and clinically relevant non-major bleeding defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.",{"measure":21,"description":22,"timeFrame":23},"Adherence to thromboprophylaxis","Percentage of participants adherent to prescribed anticoagulant thromboprophylaxis, defined as taking at least 80% of prescribed doses.","Day 7, Day 30, and Day 45",{"measure":25,"description":26,"timeFrame":23},"Medication adherence score measured by the 8-item Morisky Medication Adherence Scale (MMAS-8)","MMAS-8 total score, ranging from 0 to 8, with higher scores indicating higher medication adherence..",{"measure":28,"description":29,"timeFrame":12},"Odds ratios for factors associated with poor adherence to thromboprophylaxis","Odds ratios (ORs) with 95% confidence intervals for the association between predefined demographic and clinical factors and poor adherence to prescribed anticoagulant thromboprophylaxis.",{"measure":31,"description":32,"timeFrame":12},"Clinical characteristics associated with symptomatic venous thromboembolism","Comparison of baseline demographic and clinical characteristics between participants who develop symptomatic VTE and those who do not.",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","Adult outpatients with acute lower-limb trauma requiring immobilization who are managed in participating emergency departments or orthopedic\u002Ftrauma outpatient clinics",[39,44,49],{"label":40,"type":33,"description":41,"interventionNames":42},"LMWH Cohort","Participants with acute lower-limb trauma requiring immobilization who are prescribed low-molecular-weight heparin (LMWH) for venous thromboembolism prophylaxis according to routine clinical practice.",[43],"Drug: Low-Molecular-Weight Heparin (LMWH)",{"label":45,"type":33,"description":46,"interventionNames":47},"DOAC Cohort","Participants with acute lower-limb trauma requiring immobilization who are prescribed a direct oral anticoagulant (DOAC) for venous thromboembolism prophylaxis according to routine clinical practice.",[48],"Drug: Direct Oral Anticoagulants (DOACs)",{"label":50,"type":33,"description":51,"interventionNames":52},"No Thromboprophylaxis Cohort","Participants who do not receive pharmacological thromboprophylaxis because the treating physician determines that anticoagulation is not indicated according to routine clinical practice.",[53],"Other: No Thromboprophylaxis Cohort",[55,60,64],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":33},"DRUG","Low-Molecular-Weight Heparin (LMWH)","Low-molecular-weight heparin prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.",[40],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"Direct Oral Anticoagulants (DOACs)","Direct oral anticoagulants prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.",[45],{"type":6,"name":50,"description":65,"armGroupLabels":66,"otherNames":33},"No anticoagulant prophylaxis is prescribed as part of routine clinical care. Treatment decisions are made solely by the treating physician and are not influenced by the study",[50],[68],{"name":69,"role":70,"phone":71,"phoneExt":33,"email":72},"Nouira Semir, Professor","CONTACT","0021673106046","semir.nouira@rns.tn",[74],{"facility":75,"status":76,"city":77,"state":33,"zip":33,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"University Hospital Fattouma Bourguiba Monastir","RECRUITING","Monastir","Tunisia","TN",{"type":81,"coordinates":82},"Point",[83,84],10.82617,35.77799,{"lat":84,"lon":83},[87],{"name":69,"role":70,"phone":71,"phoneExt":33,"email":72},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Pr. Semir Nouira","Professor","100659378","trip-cast-score-validation-and-evaluation-of-adherence-to-preventive-anticoagulant-treatment-in-patients-with-lower-limb-trauma-requiring-immobilization-100659378",false,"NCT07863115","TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization","Validation of the TRiP-cast Score and Evaluation of Adherence to Preventive Anticoagulant Treatment in Non-Hospitalized Patients With Lower Limb Trauma Requiring Immobilization","TRiP-VALID","Inclusion Criteria:\n\n* Age ≥18 years.\n* Acute lower-limb trauma within 72 hours before enrollment:\n\n  * Fracture (e.g., foot, ankle, leg, or distal femur) requiring immobilization, or\n  * Grade II or III ankle or knee sprain requiring immobilization, or\n  * Acute Achilles tendon rupture requiring immediate non-surgical immobilization.\n* Immobilization with a cast or rigid orthosis (e.g., splint or walking boot) expected to last at least 7 days.\n* Initial outpatient management in an emergency department or outpatient orthopedic\u002Ftrauma clinic.\n* No planned hospitalization exceeding 24 hours for the injury or its immediate complications.\n* Written informed consent provided before study enrollment.\n\nExclusion Criteria:\n\n* Planned or initial hospitalization for more than 24 hours.\n* History of venous thromboembolism within the previous 3 months.\n* Current oral or injectable anticoagulant therapy for another indication.\n* Known major contraindication to anticoagulant therapy, including:\n\n  * Active bleeding.\n  * Untreated active peptic ulcer disease.\n  * Severe thrombocytopenia (platelet count \\\u003C50,000\u002Fmm³).\n  * Severe hepatic impairment.\n  * Severe renal impairment (estimated creatinine clearance \\\u003C30 mL\u002Fmin using the CKD-EPI equation).\n* Open lower-limb trauma requiring immediate surgery (except simple fracture reduction and immobilization).\n* Inability to understand the study procedures or provide written informed consent.\n* Pregnancy or breastfeeding.\n* Concurrent participation in another clinical study that may interfere with the objectives of the present study.","ALL","18 Years",{"count":103,"type":104},1500,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter, observational cohort study designed to externally validate the Trauma-Related Immobilization-related Prophylaxis (TRiP(cast)) score in Tunisian adults with acute lower-limb trauma requiring immobilization and managed as outpatients. The study will assess the ability of the TRiP(cast) score to identify patients at increased risk of symptomatic venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism.\n\nA secondary objective is to evaluate adherence to prescribed thromboprophylaxis and to compare adherence between patients receiving low-molecular-weight heparin (LMWH) and those receiving direct oral anticoagulants (DOACs). Factors associated with treatment adherence, bleeding events, and thromboembolic outcomes will also be investigated.\n\nPatients aged 18 years or older with acute lower-limb trauma requiring immobilization for at least 7 days will be enrolled consecutively and followed prospectively. The decision to prescribe thromboprophylaxis and the choice of anticoagulant will remain entirely at the discretion of the treating physician according to routine clinical practice. Study investigators will not influence treatment decisions. The results are expected to provide external validation of the TRiP(cast) score in the Tunisian population and improve risk stratification and thromboprophylaxis management in ambulatory patients with lower-limb trauma.",[108,109,110,111],"Lower Extremity Injuries","Venous Thromboembolism (VTE)","Deep Vein Thrombosis","Pulmonary Embolism","2026-10-01",{"date":114,"type":115},"2026-10-07","ACTUAL",{"date":117,"type":115},"2025-09-01",{"date":119,"type":104},"2028-12-31",{"name":5,"class":6},1]