Thromboprophylaxis in Lower Limb Immobilisation

Launched by QUEEN MARY UNIVERSITY OF LONDON · Apr 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Thromboprophylaxis in Lower Limb Immobilisation," aims to find out how effective different medications are in preventing blood clots in people who have an injured leg that is in a cast or splint. The main questions are whether taking tablets for blood clots works just as well as getting injections, and if any medication is better than just advice for those at lower risk of clots after a leg injury. Participants will be divided into two groups: those at high risk and those at low risk of developing clots. High-risk individuals will receive either tablets or injections, while low-risk participants might receive tablets, injections, or no medication at all.

To join the trial, participants must be at least 16 years old and have had a leg injury that requires temporary lower limb immobilization within the last week. During the trial, medications will be given for the time the leg is immobilized or up to 42 days, whichever comes first. Participants will be monitored for 90 days after they start the study. It’s important to note that certain health conditions, like severe kidney or liver problems, and other specific circumstances can exclude someone from participating. This trial is currently recruiting, and it welcomes individuals of all genders.

Gender

ALL

Eligibility criteria

• 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