THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

NCT ID: NCT05735639

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 6660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2026-12-31

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.

Conditions

Venous Thromboembolism; Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Compression therapy alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Dalteparin Sodium

Intervention Type: DRUG

Low molecular weight heparin

Tinzaparin Sodium

Intervention Type: DRUG

Low molecular weight heparin

Enoxaparin Sodium

Intervention Type: DRUG

Low molecular weight heparin

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.

Group Type: EXPERIMENTAL

Dalteparin Sodium

Intervention Type: DRUG

Low molecular weight heparin

Tinzaparin Sodium

Intervention Type: DRUG

Low molecular weight heparin

Enoxaparin Sodium

Intervention Type: DRUG

Low molecular weight heparin

Rivaroxaban

Intervention Type: DRUG

Direct oral anticoagulant

Apixaban

Intervention Type: DRUG

Direct oral anticoagulant

Dabigatran Etexilate

Intervention Type: DRUG

Direct oral anticoagulant

Interventions

Dalteparin Sodium

Low molecular weight heparin

Intervention Type: DRUG

Tinzaparin Sodium

Low molecular weight heparin

Intervention Type: DRUG

Enoxaparin Sodium

Low molecular weight heparin

Intervention Type: DRUG

Rivaroxaban

Direct oral anticoagulant

Intervention Type: DRUG

Apixaban

Direct oral anticoagulant

Intervention Type: DRUG

Dabigatran Etexilate

Direct oral anticoagulant

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sarah Whittley

Role: CONTACT

s.whittley@imperial.ac.uk

+442033117309

Facility Contacts

Alun H Davies

Role: primary

Other Identifiers

ISRCTN18501431

Identifier Type: OTHER

Identifier Source: secondary_id

22CX7510

Identifier Type: -

Identifier Source: org_study_id