THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)
THRIVE
2 other identifiers
interventional
6,660
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
January 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 24, 2026
April 1, 2026
3.4 years
January 19, 2023
April 21, 2026
Conditions
Outcome Measures
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.
90 days
Secondary Outcomes (8)
Lower limb DVT without symptoms
21 - 28 days
Lower limb DVT with symptoms
90 days
PE with symptoms
90 days
Comparisons of quality of life at 7- and 90-days post-procedure
90-days
Cost-effectiveness of providing pharmacological thromboprophylaxis
90 days
- +3 more secondary outcomes
Study Arms (3)
Compression therapy alone
NO INTERVENTIONCompression therapy + single dose of low-molecular weight heparin at time of procedure
EXPERIMENTALA 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.
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
EXPERIMENTALAn 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.
Interventions
Low molecular weight heparin
Low molecular weight heparin
Low molecular weight heparin
Direct oral anticoagulant
Direct oral anticoagulant
Direct oral anticoagulant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Hospital NHS Foundation Trust
London, W6 8RF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 21, 2023
Study Start
January 22, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share