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Thromboprophylaxis in Lower Limb Immobilisation

Study acronym: TiLLI
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Minor Study sites: 3 to 5v5
  2. Minor Primary and study completion dates: Aug 2028 to Aug 31, 2028v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 2024 to Nov 12, 2024
    v3
  4. Notable Start date: May 2024 to Sep 2024
    • Primary and study completion dates: Feb 2028 to Aug 2028
    • Eligibility criteria expanded, about 64 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06370273
Lead Sponsor Queen Mary University of London
Conditions
(from sponsor)
Thrombosis, Injury Leg
Related terms Leg Injuries, Thrombosis
Enrollment 10,044 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov