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โ† Trials
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Thromboprophylaxis in Lower Limb Immobilisation

RecruitingPhase 3Ages 16 Years - anyAllQueen Mary University of London
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In plain words

What the trial is, and whether it could suit you

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 wil

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age \>/= 16 years * Placed in temporary lower limb immobilisation (rigid cast or brace) as a result an injury that occurred within the last 7 calendar days Exclusion Criteria: * 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. * Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR \<20ml/min/1.73m2), 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. * Pregnancy, actively seeking conception, or active breastfeeding. * Preceding use of anticoagulant treatment for \>3 calendar days at prophylactic or therapeutic dose. * Prior enrolment in the TiLLI study. * Non-rigid immobilisation (crepe bandage, tubigrip support, strapping). * Time since prescription of rigid immobilisation \>3 calendar days * Co-enrolment onto a CTIMP where an anticoagulant is administered * People lacking the capacity to consent * 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
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What it tests

  • Rivaroxaban
  • Apixaban
  • Enoxaparin Injectable Solution
  • Tinzaparin Injectable Solution
  • Dalteparin Injectable Solution
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Where

5 sites
Epsom and St Helier University Hospitals NHS Trust
Carshalton, United Kingdom
Hull Teaching Hospitals NHS Trust
Hull, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom
Northern Care Alliance NHS Foundation Trust
Manchester, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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