THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Imperial College London

Status and phase: Enrolling; Phase 4

Conditions: Venous Thromboembolism; Varicose Veins

Treatments: Drug: Dabigatran Etexilate; Drug: Tinzaparin Sodium; Drug: Enoxaparin Sodium; Drug: Rivaroxaban; Drug: Dalteparin Sodium; Drug: Apixaban

Study type: Interventional

Funder types: Other

Identifiers

NCT05735639

ISRCTN18501431 (Other Identifier)

22CX7510

Details and patient eligibility

About

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.

Enrollment: 6,660 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,660 participants in 3 patient groups

Compression therapy alone

No Intervention group

Compression therapy + single dose of low-molecular weight heparin at time of procedure

Experimental group

Description:

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.

Treatment:

Drug: Dalteparin Sodium

Drug: Enoxaparin Sodium

Drug: Tinzaparin Sodium

Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC

Experimental group

Description:

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.

Treatment:

Drug: Apixaban

Drug: Rivaroxaban

Drug: Dalteparin Sodium

Drug: Enoxaparin Sodium

Drug: Tinzaparin Sodium

Drug: Dabigatran Etexilate