NCT05001776

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: National Medical Research Center for Therapy and Preventive Medicine · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Superficial Vein Thrombosis
• Endovenous Laser Ablation

Interventions

Type	Name	Description
PROCEDURE	Endovenous laser ablation	Laser ablation of the great saphenous vein close to sapheno-femoral junction
DRUG	Fondaparinux Sodium	Fondaparinux sodium for 7 days or 45 days

Timeline

• Start date: 2021-08-16
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-08-12
• Last updated: 2023-12-20

Locations

1 site across 1 country: Russia