Clinical trial NCT05735639: THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
Official title: THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Venous Thromboembolism
Varicose Veins
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 6660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 90 days
Secondary outcomes:
measure: Lower limb DVT without symptoms
timeFrame: 21 - 28 days
measure: Lower limb DVT with symptoms
timeFrame: 90 days
measure: PE with symptoms
timeFrame: 90 days
measure: Comparisons of quality of life at 7- and 90-days post-procedure
timeFrame: 90-days
measure: Cost-effectiveness of providing pharmacological thromboprophylaxis
timeFrame: 90 days
measure: Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome
timeFrame: 90 days
measure: Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome
timeFrame: 90 days
measure: Mortality rates in each group
timeFrame: 90 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Hospital NHS Foundation Trust
Study officials:
References: