Choice of the Optimal Method for Treatment of Acute Thrombophlebitis of the Varicose Great Saphenous Vein: Comparison of Endovenous Laser Ablation and Conservative Approach
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Composite of deep vein thrombosis, symptomatic pulmonary embolism, superficial vein thrombosis extension, superficial vein thrombosis recurrence or thrombosis of subfascial part of perforating veins to the level of fascia
研究概览
简要总结
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.
详细描述
Superficial venous thrombosis is a common complication in patients with varicose veins of low extremities. The most dangerous consequence of such thrombosis is its propagation to deep veins and subsequent pulmonary embolism. Recommended mode of treatment for superficial vein thrombosis is a prolonged usage of anticoagulants (preferably fondaparinux sodium for least 45 days as the best-studied approach). However, it may be not suitable for some patients, for example with a high risk of bleeding. Another possible mode of treatment is endovenous laser ablation of the saphenous vein very close to the saphenofemoral junction. This a minimally invasive procedure that may be performed ambulatory is able to decrease the risk of deep veins thrombosis and possibly allow to shorten or even eliminate the necessity of anticoagulant use. Such a suggestion was not appropriately studied in randomized clinical trials.
The aim of this prospective single-centre randomized open-label study is to compare three modes of treatment for thrombosis of varicose great saphena vein - standard medical with fondaparinux sodium, endovenous laser ablation close to the saphenofemoral junction with shortening the course of anticoagulation and endovenous laser ablation close to the saphenofemoral junction without the use of anticoagulants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endovenous laser ablation without anticoagulants
Endovenous laser ablation without using of any anticoagulant
干预措施: Endovenous laser ablation (Procedure)
Endovenous laser ablation with short-term anticoagulant
Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium
干预措施: Endovenous laser ablation (Procedure)
Endovenous laser ablation with short-term anticoagulant
Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium
干预措施: Fondaparinux Sodium (Drug)
Medical treatment
45 days of subcutaneous fondaparinux sodium
干预措施: Fondaparinux Sodium (Drug)
结局指标
主要结局
Composite of deep vein thrombosis, symptomatic pulmonary embolism, superficial vein thrombosis extension, superficial vein thrombosis recurrence or thrombosis of subfascial part of perforating veins to the level of fascia
时间窗: 45 days
All vein thrombosis should be confirmed by ultrasonography, pulmonary embolism - by computed tomography. Supreficial vein thrombosis extension - increasing size of existing thrombosis at least 2 cm. Superficial vein thrombosis recurrence - thrombosis of new superficial vein not related to index thrombosis or new thrombosis in the same superficial vein clearly separated from index thrombosis by segment on vein without signs of thrombosis at least 10 cm in length
Major bleedings
时间窗: 45 days
Major bleedings according to ISTH definition
次要结局
- Composite of deep vein thrombosis, symptomatic pulmonary embolism, superficial vein thrombosis extension, superficial vein thrombosis recurrence or thrombosis of subfascial part of perforating veins to the level of fascia(90 days)
- Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence(90 days)
- Major bleedings(90 days)
- All bleedings(90 days)
- Bleedings according to BARC criteria(90 days)