TiLLI

  • Research type

    Research Study

  • Full 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.

  • IRAS ID

    1009305

  • Contact name

    Xavier Griffin

  • Contact email

    x.griffin@qmul.ac.uk

  • Sponsor organisation

    Queen Mary University of London

  • ISRCTN Number

    ISRCTN13806452

  • Clinicaltrials.gov Identifier

    NCT06370273

  • Research summary

    People have an increased risk of blood clots when they have a leg injury treated with a plaster cast or a splint, which happens to over 70,000 people every year in the UK. Blood clots can cause long term problems in the legs and can also move to the lungs, causing serious illness and occasionally death. Medicines are available to reduce the risk of blood clots, but they can also increase the risk of bleeding. In people at high risk of clots, most hospitals use the recommended daily injections which can be uncomfortable and sometimes difficult to give. Tablets are available that reduce the risk of blood clots in other groups, but we don’t know if tablets work as well as the injections for people with a leg injury. We also don’t know whether people at low risk of blood clots may benefit from any medication.

    Our study has two aims - to determine whether giving tablets to people at high risk of clots after a leg injury is as good as injections, and whether giving any medication is better than standard care (advice only) for people at low risk of clots.

    TiLLI is two linked studies designed to answer these aims. Participates will be invited who have been placed in a plaster cast or splint after injury and are being assessed for clot risk. People who agree and are at high risk of clots will have either tablets or injections to reduce their risk; those at low risk will receive tablets, injections, or no medication. Patients and doctors will know what medication they are taking. All patients will be provided with written guidance on the signs and symptoms of blood clots and advice on managing their medication.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    24/NW/0166

  • Date of REC Opinion

    22 Jul 2024

  • REC opinion

    Further Information Favourable Opinion