Choice of the Optimal Method for Treatment of Acute Thrombophlebitis of the Varicose Great Saphenous Vein: Comparison of Endovenous Laser Ablation and Conservative Approach

05-06/21

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.

2021-08-16

2023-12-01

2023-12-01

Completed

Early phase I

105

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective single-centre open-label randomized', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

2023-12-20