RecruitingPhase 3NCT06370273

Thromboprophylaxis in Lower Limb Immobilisation

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.


Sponsor

Queen Mary University of London

Enrollment

10,044 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether taking a blood-thinning medication (an anticoagulant like apixaban or rivaroxaban) prevents dangerous blood clots in people who have had a leg injury and are wearing a cast or brace. You may be eligible if: you are 16 years or older; and you have been placed in a temporary rigid leg cast or brace due to an injury that happened within the past 7 days. You may NOT be eligible if: you need to be admitted to the hospital; you have a serious allergy or contraindication to blood thinners (such as severe kidney or liver failure); you are pregnant, breastfeeding, or trying to conceive; you are already on anticoagulants; or you are wearing a soft (non-rigid) support like an elastic bandage. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRivaroxaban

10mg once daily via oral ingestion

DRUGApixaban

2.5mg twice daily via oral ingestion

DRUGEnoxaparin Injectable Solution

40mg once daily via subcutaneous injection

DRUGTinzaparin Injectable Solution

4500 IU once daily via subcutaneous injection

DRUGDalteparin Injectable Solution

5000 IU once daily via subcutaneous injection

DRUGFondaparinux 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

View Full Details on ClinicalTrials.gov

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NCT06370273


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