Reducing the rate of blood clots in patients undergoing varicose vein treatment

Phase 4

• Conditions: VTE prevention (in patients undergoing endovenous varicose vein interventions); Circulatory System

• Registration Number: ISRCTN18501431
• Lead Sponsor: Imperial College London

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38367965/ (added 19/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-15
• Last Update Posted: 4 March 2024
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 6660

Inclusion Criteria

1. Adults (>18 years)
2. Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia
3. Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue

Exclusion Criteria

Current exclusion criteria as of 12/01/2024:
1. Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation
2. Previous personal or first-degree relative history of VTE
3. Thrombophilia
4. Female patients of childbearing potential who have a positive pregnancy test
5. A history of allergy to heparins or direct oral anticoagulants
6. A history of heparin-induced thrombocytopenia
7. Inherited and acquired bleeding disorders
8. Evidence of active bleeding
9. Concomitant major health problems such as active cancer and chronic renal and/or liver impairment
10. Known thrombocytopenia (platelets known to be less than 50 x 109/l)
11. Surgery or major trauma in the previous 90 days
12. Recent ischemic stroke in the previous 90 days
13. Inability to provide consent

Previous exclusion criteria:
1. Clinical indication for therapeutic anticoagulation
2. Clinical contraindication to anticoagulation
3. Previous personal or family history of VTE
4. Thrombophilia
5. Inability to provide informed consent or consent by personal/professional legal representative
6. A positive test for SARS-CoV2 <3 months of procedure
7. Female patients of childbearing age who have a positive pregnancy test

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ower limb deep vein thrombosis (DVT) (with or without symptoms), or pulmonary embolism (PE) with symptoms, assessed using duplex ultrasound and VTE outcome questionnaire (self-reported) at 7 days post-procedure, 21 days post-procedure, and 90 days post-procedure

Secondary Outcome Measures

Name	Time	Method
1. Lower limb DVT with or without symptoms (individual component of the composite outcome), assessed using duplex ultrasound and VTE outcome questionnaire (self-reported) at 7 days post-procedure, 21 days post-procedure, and 90 days post-procedure<br>2. PE with symptoms (individual component of the composite outcome), assessed using VTE outcome questionnaire (self-reported) at 7 days post-procedure, and 90 days post-procedure<br>3. Quality of life measured using EQ-5D at 7 days post-procedure and 90 days post-procedure<br>4. Mortality measured using a self-reported questionnaire and serious adverse event (SAE) reporting form (if applicable) at 90 days post-procedure<br>5. Cost-effectiveness of providing pharmacological thromboprophylaxis measured using Incremental Cost-Effectiveness Ratio (ICER) at 90 days post-procedure <br>6. VTE risk stratification using current risk assessment tools (Department of Health Risk Assessment [DHRA] tool, Caprini score) at baseline and up to 90 days post-procedure