THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Sponsor
Imperial College London
Study ID
NCT05735639
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Varicose Veins
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Feb 21, 2023
Start date
Jan 22, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
3,175 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Compression therapy alone
  • Experimental: Compression therapy + single dose of low-molecular weight heparin at time of procedure
    A single prophylactic dose of low molecular weight heparin (LMWH) (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) will be prescribed as per standard practice and administered in accordance with the relevant Summary of Product Characteristics (SmPC), manufacturer's recommendations and instructions for use.
  • Experimental: Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
    An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.

Primary Outcome 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. [ Time Frame: 90 days ]

Central Contacts

Related Studies