Clinical trial NCT05001776: Endovenous Laser Ablation in Acute Thrombophlebitis of the Varicose Great Saphenous Vein
Official title: Choice of the Optimal Method for Treatment of Acute Thrombophlebitis of the Varicose Great Saphenous Vein: Comparison of Endovenous Laser Ablation and Conservative Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Superficial Vein Thrombosis
Endovenous Laser Ablation
Keywords: acute thrombophlebitis
acute thrombosis
superficial vein of leg
great saphenous vein
various vein
endovenous laser ablation
fondaparinux
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2021-08-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single-centre open-label randomized
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 45 days
measure: Major bleedings
timeFrame: 45 days
Secondary outcomes:
measure: 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
timeFrame: 7 days
measure: 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
timeFrame: 90 days
measure: Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
timeFrame: 7 days
measure: Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
timeFrame: 45 days
measure: Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
timeFrame: 90 days
measure: Major bleedings
timeFrame: 7 days
measure: Major bleedings
timeFrame: 90 days
measure: All bleedings
timeFrame: 7 days
measure: All bleedings
timeFrame: 45 days
measure: All bleedings
timeFrame: 90 days
measure: Bleedings according to BARC criteria
timeFrame: 7 days
measure: Bleedings according to BARC criteria
timeFrame: Overt bleedings classified with BARC criteria
measure: Bleedings according to BARC criteria
timeFrame: 90 days
Other outcomes:
measure: Surgical intervention for superficial vein thrombosis
timeFrame: 45 days
measure: Surgical intervention for superficial vein thrombosis
timeFrame: 90 days
measure: Severity of pain
timeFrame: 7 days
measure: Severity of pain
timeFrame: 45 days
measure: Severity of pain
timeFrame: 90 days
measure: Quality of life according to 36-Item Short Form Health Status Survey
timeFrame: 7 days
measure: Quality of life according to 36-Item Short Form Health Status Survey
timeFrame: 45 days
measure: Quality of life according to 36-Item Short Form Health Status Survey
timeFrame: 90 days
measure: Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
timeFrame: 7 days
measure: Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
timeFrame: 45 days
measure: Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
timeFrame: 90 days
measure: Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
timeFrame: 7 days
measure: Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
timeFrame: 45 days
measure: Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
timeFrame: 90 days
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Therapy and Preventive Medicinel
Study officials:
affiliation: National Medical Research Center for Therapy and Preventive Medicine
name: Igor S Yavelov, MD
role: PRINCIPAL_INVESTIGATOR
References: