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Recruiting NCT05735639

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Phase IV Interventional Venous Thromboembolism Varicose Veins

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dalteparin Sodium, Tinzaparin Sodium, Enoxaparin Sodium, Rivaroxaban.
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Varicose Veins. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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. [Time frame: 90 days]
Secondary outcome measures (8)
  • Lower limb DVT without symptoms [Time frame: 21 - 28 days]
  • Lower limb DVT with symptoms [Time frame: 90 days]
  • PE with symptoms [Time frame: 90 days]
  • Comparisons of quality of life at 7- and 90-days post-procedure [Time frame: 90-days]
  • Cost-effectiveness of providing pharmacological thromboprophylaxis [Time frame: 90 days]
  • Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome [Time frame: 90 days]
  • Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome [Time frame: 90 days]
  • Mortality rates in each group [Time frame: 90 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United Kingdom · 1 center
  • Imperial College Hospital NHS Foundation Trust — London

Identifiers

NCT: NCT05735639 · 22CX7510 · ISRCTN18501431

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗