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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
6,660
Low molecular weight heparin
Low molecular weight heparin
Low molecular weight heparin
Direct oral anticoagulant
Direct oral anticoagulant
Direct oral anticoagulant
Imperial College Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGImaging 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.
Time frame: 90 days
Lower limb DVT without symptoms
Duplex ultrasound scan
Time frame: 21 - 28 days
Lower limb DVT with symptoms
Self-reported VTE outcome questionnaire
Time frame: 90 days
PE with symptoms
VTE outcome questionnaire (self-reported) to determine the rate of PE
Time frame: 90 days
Comparisons of quality of life at 7- and 90-days post-procedure
Using EQ-5D
Time frame: 90-days
Cost-effectiveness of providing pharmacological thromboprophylaxis
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 90 days
Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome
Venous thromboembolism risk as determined by the Department of Health Risk Assessment tool
Time frame: 90 days
Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome
Venous thromboembolism risk as determined by the Caprini risk assessment model
Time frame: 90 days
Mortality rates in each group
Rate of mortality
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.