[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544545":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":35,"centralContacts":62,"locations":68,"responsibleParty":139,"collaborators":35,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":35,"enrollmentInfo":151,"targetDuration":35,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":35,"overallStatus":71,"whyStopped":35,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Queen Mary University of London","OTHER",[8,15,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"TiLLI-High Intervention","ACTIVE_COMPARATOR","A non-inferiority trial in people with temporary lower limb immobilisation at high risk of VTE comparing Direct Oral AntiCoagulants (DOACs) (intervention) to parenteral prophylaxis (routine care). Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidance.\n\nIntervention medications:\n\nRivaroxaban 10mg once daily via oral ingestion. OR Apixaban 2.5mg twice daily via oral ingestion.",[13,14],"Drug: Rivaroxaban","Drug: Apixaban",{"label":16,"type":10,"description":17,"interventionNames":18},"TiLLI-High Routine Care","A non-inferiority trial in people with temporary lower limb immobilisation at high risk of VTE comparing Direct Oral AntiCoagulants (DOACs) (intervention) to parenteral prophylaxis (routine care). Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidance.\n\nRoutine Care:\n\nEnoxaparin 40mg once daily via subcutaneous injection OR Tinzaparin 4500 IU once daily via subcutaneous injection OR Dalteparin 5000 IU once daily via subcutaneous injection OR Fondaparinux 2.5mg once daily via subcutaneous injection",[19,20,21,22],"Drug: Enoxaparin Injectable Solution","Drug: Tinzaparin Injectable Solution","Drug: Dalteparin Injectable Solution","Drug: Fondaparinux Injectable Product",{"label":24,"type":10,"description":25,"interventionNames":26},"TiLLI-Low Intervention 1 (DOAC)","A superiority trial in people with temporary lower limb immobilisation at low risk of VTE comparing parenteral prophylaxis (intervention) or Direct Oral AntiCoagulants (DOACs) (intervention) to no pharmacological prophylaxis (routine care). Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidance.\n\nIntervention medication:\n\nDOACs:\n\nRivaroxaban 10mg once daily via oral ingestion. OR Apixaban 2.5mg twice daily via oral ingestion.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"TiLLI-Low Intervention 2 (Parenteral prophylaxis)","A superiority trial in people with temporary lower limb immobilisation at low risk of VTE comparing parenteral prophylaxis (intervention) or Direct Oral AntiCoagulants (DOACs) (intervention) to no pharmacological prophylaxis (routine care). Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidance.\n\nParenteral prophylaxis:\n\nEnoxaparin 40mg once daily via subcutaneous injection OR Tinzaparin 4500 IU once daily via subcutaneous injection OR Dalteparin 5000 IU once daily via subcutaneous injection OR Fondaparinux 2.5mg once daily via subcutaneous injection",[19,20,21,22],{"label":32,"type":33,"description":34,"interventionNames":35},"TiLLI-Low Routine Care","NO_INTERVENTION","A superiority trial in people with temporary lower limb immobilisation at low risk of VTE comparing parenteral prophylaxis (intervention) or Direct Oral AntiCoagulants (DOACs) (intervention) to no pharmacological prophylaxis (routine care). Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidance.\n\nRoutine care: No pharmacological prophylaxis",null,[37,42,46,50,54,58],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":35},"DRUG","Rivaroxaban","10mg once daily via oral ingestion",[9,24],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":35},"Apixaban","2.5mg twice daily via oral ingestion",[9,24],{"type":38,"name":47,"description":48,"armGroupLabels":49,"otherNames":35},"Enoxaparin Injectable Solution","40mg once daily via subcutaneous injection",[16,28],{"type":38,"name":51,"description":52,"armGroupLabels":53,"otherNames":35},"Tinzaparin Injectable Solution","4500 IU once daily via subcutaneous injection",[16,28],{"type":38,"name":55,"description":56,"armGroupLabels":57,"otherNames":35},"Dalteparin Injectable Solution","5000 IU once daily via subcutaneous injection",[16,28],{"type":38,"name":59,"description":60,"armGroupLabels":61,"otherNames":35},"Fondaparinux Injectable Product","2.5 mg once daily via subcutaneous injection",[16,28],[63],{"name":64,"role":65,"phone":66,"phoneExt":35,"email":67},"Trial Manager","CONTACT","+44 (0) 20 7882 5555","tilli-bjh@qmul.ac.uk",[69,90,103,117,125],{"facility":70,"status":71,"city":72,"state":73,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Epsom and St Helier University Hospitals NHS Trust","RECRUITING","Carshalton","Surrey","United Kingdom","UK",{"type":77,"coordinates":78},"Point",[79,80],-0.16755,51.36829,{"lat":80,"lon":79},[83,88],{"name":84,"role":65,"phone":85,"phoneExt":86,"email":87},"Rebecca Macfarlane","01372735735","6013","ESTH.EDresearch@nhs.net",{"name":84,"role":89,"phone":35,"phoneExt":35,"email":35},"PRINCIPAL_INVESTIGATOR",{"facility":91,"status":71,"city":92,"state":35,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Hull Teaching Hospitals NHS Trust","Hull",{"type":77,"coordinates":94},[95,96],-0.33525,53.7446,{"lat":96,"lon":95},[99],{"name":100,"role":65,"phone":101,"phoneExt":35,"email":102},"Jack Preece, MBBS BSc(Hons) PgDIP FRCEM","07000000000","jack.preece4@nhs.net",{"facility":104,"status":71,"city":105,"state":35,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Barts Health NHS Trust","London",{"type":77,"coordinates":107},[108,109],-0.12574,51.50853,{"lat":109,"lon":108},[112,116],{"name":113,"role":65,"phone":114,"phoneExt":35,"email":115},"Ben Bloom","02035940045","bartshealth.tmailboxedresearch@nhs.net",{"name":113,"role":89,"phone":35,"phoneExt":35,"email":35},{"facility":118,"status":71,"city":105,"state":35,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Kings College Hospital NHS Foundation Trust",{"type":77,"coordinates":120},[108,109],{"lat":109,"lon":108},[123],{"name":124,"role":65,"phone":35,"phoneExt":35,"email":35},"Thomas Hester, BSc(Hons) MBBS MRCS PGCert",{"facility":126,"status":71,"city":127,"state":35,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Northern Care Alliance NHS Foundation Trust","Manchester",{"type":77,"coordinates":129},[130,131],-2.23743,53.48095,{"lat":131,"lon":130},[134,138],{"name":135,"role":65,"phone":136,"phoneExt":35,"email":137},"Daniel Horner","0161 206 2188","acute.research@nca.nhs.uk",{"name":135,"role":89,"phone":35,"phoneExt":35,"email":35},{"type":140,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100544545","phase-3-thromboprophylaxis-in-lower-limb-immobilisation-100544545",false,"NCT06370273","Thromboprophylaxis in Lower Limb Immobilisation","Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.","TiLLI","Inclusion Criteria:\n\n* Age \\>\u002F= 16 years\n* Placed in temporary lower limb immobilisation (rigid cast or brace) as a result an injury that occurred within the last 7 calendar days\n\nExclusion Criteria:\n\n* Hospital admission is required direct from the emergency department, minor injuries unit, or fracture clinic setting with an expected length of stay \\>2 calendar days.\n* Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR \\\u003C20ml\u002Fmin\u002F1.73m2), hepatic failure or use of concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g. ritonavir) or active substances strongly inhibiting elimination pathways such as CYP3A4 or P-gp (such as clarithromycin, erythromycin or dronaderone) or a history of heparin induced thrombocytopenia.\n* Pregnancy, actively seeking conception, or active breastfeeding.\n* Preceding use of anticoagulant treatment for \\>3 calendar days at prophylactic or therapeutic dose.\n* Prior enrolment in the TiLLI study.\n* Non-rigid immobilisation (crepe bandage, tubigrip support, strapping).\n* Time since prescription of rigid immobilisation \\>3 calendar days\n* Co-enrolment onto a CTIMP where an anticoagulant is administered\n* People lacking the capacity to consent\n* Inability or refusal to use acceptable contraception up until after the last administration of IMP. Only applicable for women of childbearing potential who have been randomised to receive apixaban or rivaroxaban","ALL","16 Years",{"count":152,"type":153},10044,"ESTIMATED","INTERVENTIONAL",[156],"PHASE3","The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.\n\nThe main questions it aims to answer are:\n\n* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)\n* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.\n\nParticipants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.\n\nDrug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.",[159,160],"Thrombosis","Injury Leg","2026-07-01",{"date":163,"type":164},"2026-07-02","ACTUAL",{"date":166,"type":164},"2024-11-12",{"date":168,"type":153},"2028-08-31",{"name":5,"class":6},5]