Venous Thromboembolism, Varicose Veins
Conditions
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.
Interventions
Low molecular weight heparin
Low molecular weight heparin
DRUGEnoxaparin Sodium
Low molecular weight heparin
DRUGRivaroxaban
Direct oral anticoagulant
DRUGApixaban
Direct oral anticoagulant
DRUGDabigatran Etexilate
Direct oral anticoagulant
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Lower limb DVT with symptoms | 90 days | Self-reported VTE outcome questionnaire |
| PE with symptoms | 90 days | VTE outcome questionnaire (self-reported) to determine the rate of PE |
| Comparisons of quality of life at 7- and 90-days post-procedure | 90-days | Using EQ-5D |
| Lower limb DVT without symptoms | 21 - 28 days | Duplex ultrasound scan |
| Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome | 90 days | Venous thromboembolism risk as determined by the Department of Health Risk Assessment tool |
| Mortality rates in each group | 90 days | Rate of mortality |
| Cost-effectiveness of providing pharmacological thromboprophylaxis | 90 days | Incremental Cost-Effectiveness Ratio (ICER) |
Countries
United Kingdom
Contacts
Primary ContactSarah Whittley
Outcome results
None listed