THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Sponsor

Imperial College London (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05735639

Collaborator

(none)

6,660

Enrollment

Location

Arms

Anticipated Duration (Months)

170.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Varicose Veins	Drug: Dalteparin Sodium Drug: Tinzaparin Sodium Drug: Enoxaparin Sodium Drug: Rivaroxaban Drug: Apixaban Drug: Dabigatran Etexilate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6660 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Dalteparin Sodium Low molecular weight heparin Drug: Tinzaparin Sodium Low molecular weight heparin Drug: Enoxaparin Sodium Low molecular weight heparin
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.	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

Arm

Intervention/Treatment

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.

Drug: Dalteparin Sodium

Low molecular weight heparin

Drug: Tinzaparin Sodium

Low molecular weight heparin

Drug: Enoxaparin Sodium

Low molecular weight heparin

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.

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

Outcome Measures

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. [90 days]
The rate of lower limb DVT with or without symptoms, or PE with symptoms within 90 days of varicose vein treatment.

Secondary Outcome Measures

Quality of Life [7 and 90-days]
Quality of Life assessed using the EQ-5D
Mortality [90 days]
Health Economic Outcome [90 days]
Incremental Cost-Effectiveness Ratio (ICER)
Effectiveness of VTE risk stratification using current risk assessment tools [90 days]
Sub-group analyses of the following risk assessment tools: Department of Health Risk Assessment Tool, Caprini Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
Clinical contraindication to anticoagulation
Previous personal or family history of VTE
Thrombophilia
Inability to provide informed consent or consent by personal/professional legal representative
Female patients of childbearing age who have a positive pregnancy test
A positive test for SARS-CoV2 <3 months of procedure