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

NCT05001776 | Completed Phase 4 DMC

• 1 other identifier: 05-06/21
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

  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

  90 days

• Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence

  7 days

• Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence

  45 days

• Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence

  90 days

Other Outcomes (14)

• Surgical intervention for superficial vein thrombosis

  45 days

• Surgical intervention for superficial vein thrombosis

  90 days

• Severity of pain

  7 days

Study Arms (3)

Endovenous laser ablation without anticoagulants

ACTIVE COMPARATOR

Endovenous laser ablation without using of any anticoagulant

Procedure: Endovenous laser ablation

Endovenous laser ablation with short-term anticoagulant

ACTIVE COMPARATOR

Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium

Procedure: Endovenous laser ablation; Drug: Fondaparinux Sodium

Medical treatment

ACTIVE COMPARATOR

45 days of subcutaneous fondaparinux sodium

Drug: Fondaparinux Sodium

Interventions

Endovenous laser ablation PROCEDURE

Laser ablation of the great saphenous vein close to sapheno-femoral junction

Also known as: Ablation of varicose vein

Endovenous laser ablation with short-term anticoagulant; Endovenous laser ablation without anticoagulants

Fondaparinux Sodium DRUG

Fondaparinux sodium for 7 days or 45 days

Also known as: Anticoagulation

Endovenous laser ablation with short-term anticoagulant; Medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicinel

Moscow, 10100, Russia

Location

MeSH Terms

Interventions

Fondaparinux

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Igor S Yavelov, MD

  National Medical Research Center for Therapy and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective single-centre open-label randomized

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 12, 2021
• Study Start: August 16, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

RU (1)