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.

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 10044

Inclusion Criteria

1. Age >=16 years
2. Placed in temporary lower limb immobilisation (rigid cast or brace) as a result of an injury that occurred within the last 7 calendar days

Exclusion Criteria

1.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.
2.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.
3.Pregnancy, actively seeking conception, or active breastfeeding.
4.Preceding use of anticoagulant treatment for >3 calendar days at prophylactic or therapeutic dose
5.Previous enrolment in the TiLLI study.
6.Non-rigid immobilisation (crepe bandage, tubigrip support, strapping).
7.Time since prescription of rigid immobilisation >3 calendar days.
8.Co-enrolment onto a CTIMP where an anticoagulant is administered.
9.People lacking the capacity to consent.
10.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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite primary outcome of net clinical benefit, comprising symptomatic VTE events (any deep vein thrombosis or pulmonary embolism), major bleeding or cause-specific mortality (death from either pulmonary embolus or major bleeding) within 90 days used as a binary variable (‘1’ if any event occurred, ‘0’ of none of the events occurred).

Secondary Outcome Measures

Name	Time	Method

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