Preventing blood clots in patients with leg injuries in casts or splints
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.
This study is testing whether giving tablets or injections to prevent blood clots can help people with leg injuries in casts or splints feel safer compared to standard care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10044 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 3 sites (Carshalton, Surrey and 2 other locations) |
| Trial ID | NCT06370273 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and cost-effectiveness of thromboprophylaxis in patients who have sustained leg injuries requiring immobilization. Participants will be categorized as high or low risk for blood clots and will receive either tablets or injections to reduce their risk. The study will compare the efficacy of these treatments against standard care, which may involve no medication for low-risk individuals. Follow-up assessments will occur for 90 days post-randomization to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who have been placed in a temporary lower limb immobilization device due to a recent leg injury.
Not a fit: Patients who require hospital admission for more than two days or have contraindications to anticoagulants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer and more effective options for preventing blood clots in patients with leg injuries.
How similar studies have performed: Previous studies have indicated the need for further investigation into thromboprophylaxis in similar patient populations, suggesting this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Carshalton, Surrey and 2 other locations
- Epsom and St Helier University Hospitals NHS Trust — Carshalton, Surrey, United Kingdom (Recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Northern Care Alliance NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Trial Manager
- Email: tilli-bjh@qmul.ac.uk
- Phone: +44 (0) 20 7882 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.