protocolSection identificationModule nctId: NCT06370273, orgStudyIdInfo id: 1009305, briefTitle: Thromboprophylaxis in Lower Limb Immobilisation, acronym: TiLLI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: 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.The main questions it aims to answer are:* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.Participants 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.Drug 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., conditionsModule conditions: Thrombosis, conditions: Injury Leg, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A pragmatic, open-label, linked pair of randomised controlled trials with common outcomes and parallel economic analysis each with internal pilot phases, conducted across 30 NHS sites, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Open-label study. Trial Statistician and Health Economist to be blinded for analysis, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10044, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban, interventions name: Apixaban, interventions name: Enoxaparin Injectable Solution, interventions name: Tinzaparin Injectable Solution, interventions name: Dalteparin Injectable Solution, interventions name: Fondaparinux Injectable Product, outcomesModule primaryOutcomes measure: Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality, secondaryOutcomes measure: Symptomatic VTE event occurrence, secondaryOutcomes measure: Major bleeding occurrence, secondaryOutcomes measure: Cause-specific mortality occurrence, secondaryOutcomes measure: Adverse and Serious adverse events, secondaryOutcomes measure: Medication adherence, secondaryOutcomes measure: Health utility (EQ-5D-5L), secondaryOutcomes measure: Patient satisfaction regarding the burdens and benefits of anticoagulation, secondaryOutcomes measure: Hospital readmission/reattendance, secondaryOutcomes measure: Health and social care resource use, secondaryOutcomes measure: Patient longer term outcome VTE and bleeding data, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False