Health TrialsbyHealthPanel

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

ConditionsVenous ThromboembolismVaricose Veins
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dalteparin Sodium

    Drug

    Low molecular weight heparin

  • Tinzaparin Sodium

    Drug

    Low molecular weight heparin

  • Enoxaparin Sodium

    Drug

    Low molecular weight heparin

  • Rivaroxaban

    Drug

    Direct oral anticoagulant

  • Apixaban

    Drug

    Direct oral anticoagulant

  • Dabigatran Etexilate

    Drug

    Direct oral anticoagulant

Treatment groups

3,175 Participants
are divided into 3 treatment groups
Group A: Compression therapy aloneNo intervention 0 interventions
Group B: Compression therapy + single dose of low-molecular weight heparin at time of procedureExperimental treatment 3 interventions
Group C: Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOACExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days

Secondary outcomes

1

Lower limb DVT without symptoms

Duplex ultrasound scan

Time frame
21 - 28 days
2

Lower limb DVT with symptoms

Self-reported VTE outcome questionnaire

Time frame
90 days
3

PE with symptoms

VTE outcome questionnaire (self-reported) to determine the rate of PE

Time frame
90 days
4

Comparisons of quality of life at 7- and 90-days post-procedure

Using EQ-5D

Time frame
90-days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Source ClinicalTrials.gov
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