THRIVE

  • Research type

    Research Study

  • Full title

    THRomboprophylaxis in Individuals undergoing superficial endoVEnouos treatment (THRIVE): a multicentre assessor-blind randomised controlled trial

  • IRAS ID

    1007271

  • Contact name

    Alun Davies

  • Contact email

    a.h.davies@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Eudract number

    2023-000217-40

  • Research summary

    Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg, known as deep veins. Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins
    happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other problems. If a clot in the leg travels to the lungs, it may be life-threatening.

    Medicines to reduce the blood's tendency to form clots are often prescribed to patients at high risk of blood clots. However, it is unclear if these clot reducing medicines are beneficial in preventing blood clots in people having these varicose vein procedures. Elastic stockings that squeeze the leg and improve the blood flow through the veins are applied after the varicose vein procedure which helps to reduce the risk of blood clots.

    This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures. People enrolled in the study will undergo an assessment to make sure that they don’t have the most important risk factors for clots. People enrolled in the study will be over 18 years of age and will receive stockings along with, at random, one of the following three treatments:
    i) No clot-reducing medicine, or
    ii) Single dose of clot-reducing medicine, or
    iii) Extended course (7-14 days) of clot-reducing medicine

    Everyone in the study will get an ultrasound scan at 21 days after their operation to check they have not developed a blood clot. This scan is not routinely performed in the NHS and is an additional scan to ensure that all blood clots are detected early. Participants will receive a phone call at day 90 to see if they have developed a blood clot or had any problems with the treatment.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    23/LO/0261

  • Date of REC Opinion

    13 Sep 2023

  • REC opinion

    Further Information Favourable Opinion