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

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.

Study Overview

• Status: Completed
• Conditions: Endovenous Laser Ablation; Superficial Vein Thrombosis
• Intervention / Treatment: Procedure: Endovenous laser ablation; Drug: Fondaparinux Sodium

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 10100
    • National Medical Research Center for Therapy and Preventive Medicinel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Medical Research Center for Therapy and Preventive Medicine
• Investigators: Principal Investigator: Igor S Yavelov, MD, National Medical Research Center for Therapy and Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: fondaparinux; endovenous laser ablation; great saphenous vein; acute thrombophlebitis; acute thrombosis; superficial vein of leg; various vein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Peripheral Vascular Diseases; Phlebitis; Thrombosis; Thrombophlebitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Fondaparinux; PENTA
• Other Study ID Numbers: 05-06/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No