Endovenous Laser Ablation in Acute Thrombophlebitis of the Varicose Great Saphenous Vein

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Рrospective single-centre randomized open-label study for comparison three modes of treatment for thrombosis of varicose great saphena vein - standard medical with fondaparinux sodium for 45 days, endovenous laser ablation close to the saphenofemoral junction with a 7-day course of anticoagulation and endovenous laser ablation close to the saphenofemoral junction without the use of anticoagulants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Medical Research Center for Therapy and Preventive Medicine
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

• Age 18 years or more

• Acute thrombosis of varicose great saphenous vein and/or its major branches more than 5 cm from the saphenofemoral junction

• Signed informed consent

Exclusion Criteria:

• More than 3 weeks after symptom onset

• Ultrasound signs of deep vein thrombosis

• Suspected pulmonary embolism

• Superficial vein thrombosis within 5 cm from the saphenofemoral junction

• Bilateral superficial vein thrombosis

• Thrombosis of subfascial part of perforating veins to the level of fascia

• Thrombosis of small saphenous vein

• Superficial vein thrombosis associated with sclerotherapy

• History of deep vein thrombosis and/or pulmonary embolism

• Superficial vein thrombosis within 3 months before inclusion

• Anemia (haemoglobin less than 90 g/l)

• Low platelet count (less than 100 X 109/l)

• Severe renal impairment (calculated GFR less than 20 ml/min/1,73 m2)

• Body mass less than 50 kg

• Morbid obesity (BMI higher than 40 kg/m2)

• Allergy to fondaparinux sodium and local anaesthetics

• Using anticoagulants for treating the current episode of venous thrombosis

• Using anticoagulants for other medical conditions (e.g. atrial fibrillation)

• Double antiplatelet therapy

• Regular use of NSAIDs (except aspirin less than 325 mg daily)

• High risk of bleeding according to an investigator

• Active clinically relevant bleeding

• Clinically relevant bleeding within last 30 days before inclusion

• Major surgery of severe head trauma within last 30 days before inclusion

• Ophthalmic, spinal or cerebral surgery within last 12 months

• Active gastric or duodenum ulcer, erosive and ulcerative gastrointestinal disorder

• Documented haemorrhagic diathesis

• Uncontrolled arterial hypertension (systolic[180 mm Hg, diastolic[110 mm Hg)

• Active cancer, history of cancer

• Acute illness, decompensation of chronic illness

• Autoimmune disease, treatment of autoimmune disease

• Severe chronic heart failure and/or marked oedema due to heart failure

• Severe pulmonary insufficiency

• Bacterial endocarditis

• Severe renal failure

• Known severe thrombophilia (antiphospholipid syndrome, a deficit of antithrombin, a deficit of protein C, S, factor V Leiden, prothrombin G20210A)

• Immobility, unable to increase mobility

• Pregnant or breastfeeding women

• Alcohol abuse, drugs abuse or other circumstances indication low compliance

• Unwilling of unable to follow requirements of the protocol