THRomboprophylaxis in Individuals undergoing superficial endoVEnouos treatment (THRIVE): a multicentre assessor-blind randomized controlled trial
VTE prevention (in patients undergoing endovenous varicose vein interventions)
Participants (n = 6,660) will undergo 1:1:1 web-based randomization to one of three thromboprophylaxis strategies prior to undergoing endovenous treatment. Randomization will be conducted through an automated system linked to the eCRF setup via the Study Data Centre at the Edinburgh Clinical Trials Unit. Participants will be individually randomized to one of three thromboprophylaxis strategies prior to undergoing endovenous treatment: 1. Compression therapy alone 2. Compression therapy + a single dose of low-molecular-weight heparin (LMWH) at the time of the procedure 3. Compression therapy + a single dose of LMWH at the time of the procedure + extended prophylactic dose of anticoagulation with LMWH or direct-acting oral anticoagulants (DOAC)
1. Adults (>18 years) 2. Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia 3. Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue
Current exclusion criteria as of 06/03/2025: 1. Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation 2. Previous personal or first-degree relative history of VTE 3. Thrombophilia 4. Female patients of childbearing potential who have a positive pregnancy test 5. A history of allergy to heparins or direct oral anticoagulants 6. A history of heparin-induced thrombocytopenia 7. Inherited and acquired bleeding disorders 8. Evidence of active bleeding 9. Concomitant major health problems such as active cancer and chronic renal and/or liver impairment 10. Known thrombocytopenia (platelets known to be less than 50 x 10^9/l) 11. Major trauma or non-venous surgery that required local risk assessment for VTE in the previous 90 days 12. Recent ischemic stroke in the previous 90 days 13. Inability to provide consent _____ Previous exclusion criteria as of 12/01/2024: 1. Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation 2. Previous personal or first-degree relative history of VTE 3. Thrombophilia 4. Female patients of childbearing potential who have a positive pregnancy test 5. A history of allergy to heparins or direct oral anticoagulants 6. A history of heparin-induced thrombocytopenia 7. Inherited and acquired bleeding disorders 8. Evidence of active bleeding 9. Concomitant major health problems such as active cancer and chronic renal and/or liver impairment 10. Known thrombocytopenia (platelets known to be less than 50 x 10^9/l) 11. Surgery or major trauma in the previous 90 days 12. Recent ischemic stroke in the previous 90 days 13. Inability to provide consent _____ Previous exclusion criteria: 1. Clinical indication for therapeutic anticoagulation 2. Clinical contraindication to anticoagulation 3. Previous personal or family history of VTE 4. Thrombophilia 5. Inability to provide informed consent or consent by personal/professional legal representative 6. A positive test for SARS-CoV2