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Thromboprophylaxis in Lower Limb Immobilisation
Sponsor: Queen Mary University of London
Summary
The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury. The main questions it aims to answer are: * whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care) * whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots. Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication. Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.
Official title: 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.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10044
Start Date
2024-11-12
Completion Date
2028-08-31
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
Rivaroxaban
10mg once daily via oral ingestion
Apixaban
2.5mg twice daily via oral ingestion
Enoxaparin Injectable Solution
40mg once daily via subcutaneous injection
Tinzaparin Injectable Solution
4500 IU once daily via subcutaneous injection
Dalteparin Injectable Solution
5000 IU once daily via subcutaneous injection
Fondaparinux Injectable Product
2.5 mg once daily via subcutaneous injection
Locations (3)
Epsom and St Helier University Hospitals NHS Trust
Carshalton, Surrey, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Northern Care Alliance NHS Foundation Trust
Manchester, United Kingdom