THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Venous Thromboembolism Clinical Trial

— THRIVE  

Official title:

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735639
• Other study ID #: 22CX7510
• Secondary ID: ISRCTN18501431
• Status: Recruiting
• Phase: Phase 4
• Start date: January 22, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Imperial College London
• Contact: Sarah Whittley
• Phone: +442033117309
• Email: s.whittley[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. 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). 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 long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening. Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures. This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6660
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (>18 years)
• Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia
• Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue

Exclusion Criteria:

• Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation
• Previous personal or first-degree relative history of VTE
• Thrombophilia
• Female patients of childbearing potential who have a positive pregnancy test
• A history of allergy to heparins or direct oral anticoagulants
• A history of heparin-induced thrombocytopenia
• Inherited and acquired bleeding disorders
• Evidence of active bleeding
• Concomitant major health problems such as active cancer and chronic renal and/or liver impairment
• Known thrombocytopenia (platelets known to be less than 50 x 109 /l)
• Surgery or major trauma in the previous 90 days
• Recent ischemic stroke in the previous 90 days
• Inability to provide consent

Related Conditions & MeSH terms

• Thromboembolism
• Varicose Veins
• Venous Thromboembolism

Intervention

Drug:
• Dalteparin Sodium
Low molecular weight heparin
• Tinzaparin Sodium
Low molecular weight heparin
• Enoxaparin Sodium
Low molecular weight heparin
• Rivaroxaban
Direct oral anticoagulant
• Apixaban
Direct oral anticoagulant
• Dabigatran Etexilate
Direct oral anticoagulant

Locations

Country	Name	City	State
United Kingdom	Imperial College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging confirmed lower limb deep vein thrombosis (DVT) with or without symptoms, or pulmonary embolism (PE) with symptoms within 90 days of varicose vein treatment.	The rate of lower limb DVT with or without symptoms, or PE with symptoms within 90 days of varicose vein treatment.	90 days
Secondary	Lower limb DVT without symptoms	Duplex ultrasound scan	21 - 28 days
Secondary	Lower limb DVT with symptoms	Self-reported VTE outcome questionnaire	90 days
Secondary	PE with symptoms	VTE outcome questionnaire (self-reported) to determine the rate of PE	90 days
Secondary	Comparisons of quality of life at 7- and 90-days post-procedure	Using EQ-5D	90-days
Secondary	Cost-effectiveness of providing pharmacological thromboprophylaxis	Incremental Cost-Effectiveness Ratio (ICER)	90 days
Secondary	Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome	Venous thromboembolism risk as determined by the Department of Health Risk Assessment tool	90 days
Secondary	Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome	Venous thromboembolism risk as determined by the Caprini risk assessment model	90 days
Secondary	Mortality rates in each group	Rate of mortality	90 days