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Ð rospective 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovenous laser ablation without anticoagulants | Active Comparator | Endovenous laser ablation without using of any anticoagulant |
|
| Endovenous laser ablation with short-term anticoagulant | Active Comparator | Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium |
|
| Medical treatment | Active Comparator | 45 days of subcutaneous fondaparinux sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovenous laser ablation | Procedure | Laser ablation of the great saphenous vein close to sapheno-femoral junction |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical intervention for superficial vein thrombosis | Requirement of unplanned surgical intervention for treatment of superficial vein thrombosis | 45 days |
| Surgical intervention for superficial vein thrombosis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor S Yavelov, MD | National Medical Research Center for Therapy and Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center for Therapy and Preventive Medicinel | Moscow | 10100 | Russia |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Prospective single-centre open-label randomized
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| Fondaparinux Sodium | Drug | Fondaparinux sodium for 7 days or 45 days |
|
|
| 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 |
Requirement of unplanned surgical intervention for treatment of superficial vein thrombosis
| 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 90 days |