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

NCT ID: NCT05001776

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2023-12-01

Brief Summary

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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

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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

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Superficial Vein Thrombosis Endovenous Laser Ablation

Keywords

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acute thrombophlebitis acute thrombosis superficial vein of leg great saphenous vein various vein endovenous laser ablation fondaparinux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective single-centre open-label randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovenous laser ablation without anticoagulants

Endovenous laser ablation without using of any anticoagulant

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation

Intervention Type PROCEDURE

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

Endovenous laser ablation with short-term anticoagulant

Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation

Intervention Type PROCEDURE

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

Fondaparinux Sodium

Intervention Type DRUG

Fondaparinux sodium for 7 days or 45 days

Medical treatment

45 days of subcutaneous fondaparinux sodium

Group Type ACTIVE_COMPARATOR

Fondaparinux Sodium

Intervention Type DRUG

Fondaparinux sodium for 7 days or 45 days

Interventions

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Endovenous laser ablation

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

Intervention Type PROCEDURE

Fondaparinux Sodium

Fondaparinux sodium for 7 days or 45 days

Intervention Type DRUG

Other Intervention Names

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Ablation of varicose vein Anticoagulation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor S Yavelov, MD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center for Therapy and Preventive Medicine

Locations

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National Medical Research Center for Therapy and Preventive Medicinel

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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05-06/21

Identifier Type: -

Identifier Source: org_study_id