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Thromboprophylaxis in Lower Limb Immobilisation

NCT06370273 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10044

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370273 on ClinicalTrials.gov