Eligibility
Local study conflicts
- Any co-enrollment conflicts
Inclusion Criteria:
- Age 16 years and above
- 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:
- 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.
- Previous 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.
If the patient is eligible:
Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition;
- If they change their mind they can withdraw their participation at any point
Step by Step Guide to Recruitment:
In standard working hours; Mon-fri 07:30-16:30
- Contact the trauma hub on 07889 476009
Out of hours and weekends:
- To be updated