Actively Recruiting

Phase 3
Age: 16Years +
All Genders
NCT06370273

Thromboprophylaxis in Lower Limb Immobilisation

Led by Queen Mary University of London · Updated on 2026-01-06

10044

Participants Needed

3

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Thromboprophylaxis in Lower Limb Immobilisation

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3e= 16 years
  • Placed in temporary lower limb immobilisation (rigid cast or brace) due to a leg injury within the last 7 calendar days
Not Eligible

You will not qualify if you...

  • Expected hospital stay longer than 2 days upon admission
  • Known allergy or absolute contraindication to anticoagulants, including severe kidney or liver failure or certain drug interactions
  • Pregnancy, actively seeking conception, or breastfeeding
  • Use of anticoagulant treatment for more than 3 days before the study
  • Previous participation in the TiLLI study
  • Use of non-rigid immobilisation such as crepe bandage or tubigrip
  • More than 3 days since rigid immobilisation was prescribed
  • Participation in another trial involving anticoagulants
  • Lack of capacity to consent
  • Refusal or inability to use contraception during study if assigned to certain medications and of childbearing potential

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Epsom and St Helier University Hospitals NHS Trust

Carshalton, Surrey, United Kingdom

Actively Recruiting

2

Barts Health NHS Trust

London, United Kingdom

Actively Recruiting

3

Northern Care Alliance NHS Foundation Trust

Manchester, United Kingdom

Actively Recruiting

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Research Team

T

Trial Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

5

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