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RECRUITING
NCT06370273
PHASE3

Thromboprophylaxis in Lower Limb Immobilisation

Sponsor: Queen Mary University of London

View on ClinicalTrials.gov

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

Interventions

DRUG

Rivaroxaban

10mg once daily via oral ingestion

DRUG

Apixaban

2.5mg twice daily via oral ingestion

DRUG

Enoxaparin Injectable Solution

40mg once daily via subcutaneous injection

DRUG

Tinzaparin Injectable Solution

4500 IU once daily via subcutaneous injection

DRUG

Dalteparin Injectable Solution

5000 IU once daily via subcutaneous injection

DRUG

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