A Phase 4 interventional study of Endovenous laser ablation and Fondaparinux Sodium in Superficial Vein Thrombosis and Endovenous Laser Ablation, sponsored by National Medical Research Center for Therapy and Preventive Medicine. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by National Medical Research Center for Therapy and Preventive Medicine · Phase 4, Interventional, and Treatment
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.
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.
National Medical Research Center for Therapy and Preventive Medicine is the lead sponsor of 29 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endovenous laser ablation without using of any anticoagulant
Procedure: Endovenous laser ablation
Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium
Procedure: Endovenous laser ablation · Drug: Fondaparinux Sodium
45 days of subcutaneous fondaparinux sodium
Drug: Fondaparinux Sodium
Laser ablation of the great saphenous vein close to sapheno-femoral junction
Also known as: Ablation of varicose vein
Fondaparinux sodium for 7 days or 45 days
Also known as: Anticoagulation
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
Time frame: 45 days
Major bleedings
Major bleedings according to ISTH definition
Time frame: 45 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 90 days
Major bleedings
Major bleedings according to ISTH definition
Time frame: 7 days
Major bleedings
Major bleedings according to ISTH definition
Time frame: 90 days
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
Time frame: 7 days
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
Time frame: 45 days
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor
Time frame: 90 days
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Time frame: 7 days
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Time frame: Overt bleedings classified with BARC criteria
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Time frame: 90 days
Surgical intervention for superficial vein thrombosis
Requirement of unplanned surgical intervention for treatment of superficial vein thrombosis
Time frame: 45 days
Surgical intervention for superficial vein thrombosis
Requirement of unplanned surgical intervention for treatment of superficial vein thrombosis
Time frame: 90 days
Severity of pain
10 cm visual analog scale of pain and 0-10 numeric pain rating score (0 - no pain, 10 - worst imaginable pain)
Time frame: 7 days
Severity of pain
10 cm visual analog scale of pain and 0-10 numeric pain rating score (0 - no pain, 10 - worst imaginable pain)
Time frame: 45 days
Severity of pain
10 cm visual analog scale of pain and 0-10 numeric pain rating score (0 - no pain, 10 - worst imaginable pain)
Time frame: 90 days
Quality of life according to 36-Item Short Form Health Status Survey
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: 7 days
Quality of life according to 36-Item Short Form Health Status Survey
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: 45 days
Quality of life according to 36-Item Short Form Health Status Survey
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: 90 days
Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
Zero score is equivalent to no disability and a score of 10 is equivalent to maximal disability
Time frame: 7 days
Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
Zero score is equivalent to no disability and a score of 10 is equivalent to maximal disability
Time frame: 45 days
Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
Zero score is equivalent to no disability and a score of 10 is equivalent to maximal disability
Time frame: 90 days
Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: 7 days
Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: 45 days
Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: 90 days
Ran from Aug 2021 to primary completion in Dec 2023, 27 months.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fondaparinux
National Medical Research Center for Therapy and Preventive Medicine