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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Superficial Vein Thrombosis, Endovenous Laser Ablation

Intervention / Treatment
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* Procedure: Endovenous laser ablation
* Drug: Fondaparinux Sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective single-centre open-label randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovenous laser ablation without anticoagulants<br>Endovenous laser ablation without using of any anticoagulant | Procedure: Endovenous laser ablation<br>* Laser ablation of the great saphenous vein close to sapheno-femoral junction<br>* Other names: Ablation of varicose vein;|
| Active Comparator: Endovenous laser ablation with short-term anticoagulant<br>Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium | Procedure: Endovenous laser ablation<br>* Laser ablation of the great saphenous vein close to sapheno-femoral junction<br>* Other names: Ablation of varicose vein;Drug: Fondaparinux Sodium<br>* Fondaparinux sodium for 7 days or 45 days<br>* Other names: Anticoagulation;|
| Active Comparator: Medical treatment<br>45 days of subcutaneous fondaparinux sodium | Drug: Fondaparinux Sodium<br>* Fondaparinux sodium for 7 days or 45 days<br>* Other names: Anticoagulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 45 days | 
| Major bleedings | Major bleedings according to ISTH definition | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 7 days | 
| 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 | 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 | 90 days | 
| Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence | 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 | 7 days | 
| Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence | 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 | 45 days | 
| Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence | 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 | 90 days | 
| Major bleedings | Major bleedings according to ISTH definition | 7 days | 
| Major bleedings | Major bleedings according to ISTH definition | 90 days | 
| All bleedings | All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria | 7 days | 
| All bleedings | All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria | 45 days | 
| All bleedings | All overt bleedings classified as major, clinically relevant non-major and minor | 90 days | 
| Bleedings according to BARC criteria | Overt bleedings classified with BARC criteria | 7 days | 
| Bleedings according to BARC criteria | Overt bleedings classified with BARC criteria | Overt bleedings classified with BARC criteria | 
| Bleedings according to BARC criteria | Overt bleedings classified with BARC criteria | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute thrombosis, acute thrombophlebitis, superficial vein of leg, great saphenous vein, various vein, endovenous laser ablation, fondaparinux