Preventing blood clots in patients with leg injuries in casts or splints

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Epsom and St Helier University Hospitals NHS Trust
  Carshalton, Surrey, United Kingdom Recruiting
• Hull Teaching Hospitals NHS Trust
  Hull, United Kingdom Recruiting
• Barts Health NHS Trust
  London, United Kingdom Recruiting
• Kings College Hospital NHS Foundation 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Thromboelastometry to Predict Thrombosis and Survival in Glial Tumor Surgery

  Aimed at people with glial tumors undergoing surgery, the study tests whether thromboelastometry and other blood tests can predict blood-clot risk and survival.

  Recruiting Fundacion Clinic per a la Recerca Biomédica · Barcelona · NCT07813377

• Personalized blood-thinner plan for leg artery disease after repair

  A personalized plan using a blood test to tailor antiplatelet therapy is being tested against standard treatment in adults with PAD after a procedure to restore blood flow.

  Recruiting at 2 sites Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07613840

• Multi-omics search for clotting and bleeding markers in coronary heart disease

  This project will test whether combining proteins, metabolites, genes, sugar tags, and heart images can better predict clotting and major bleeding in people with coronary heart disease on dual antiplatelet therapy.

  Recruiting at 3 sites Chinese Academy of Medical Sciences, Fuwai Hospital · Zhengzhou, Henan and 2 other locations · NCT07523880

• Gruticibart to Prevent Catheter-Related Blood Clots

  This phase II trial tests whether a single dose of gruticibart can prevent blood clots caused by a central venous catheter in adults.

  Recruiting Phase 2 OHSU Knight Cancer Institute · Portland, Oregon · NCT07498517

• Apixaban vs Warfarin in HeartMate 3 LVAD Patients

  This study tests whether apixaban can replace warfarin to prevent clots and bleeding problems in adults with an implanted HeartMate 3 LVAD for at least 3 months.

  Recruiting Phase 3 Columbia University · New York, New York · NCT07471139

• Safety of perioperative blood thinner management in people with cancer undergoing surgery or procedures

  This study tests how safe current practices are for stopping or continuing blood thinners in adults with cancer who are having surgery or procedures, to see if bleeding or clots are affected.

  Recruiting Ottawa Hospital Research Institute · Ottawa · NCT07372716

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.