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

Primary Purpose

Superficial Vein Thrombosis, Endovenous Laser Ablation

Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Endovenous laser ablation
Fondaparinux Sodium
Sponsored by
National Medical Research Center for Therapy and Preventive Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Vein Thrombosis focused on measuring acute thrombophlebitis, acute thrombosis, superficial vein of leg, great saphenous vein, various vein, endovenous laser ablation, fondaparinux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Medical Research Center for Therapy and Preventive MedicinelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Endovenous laser ablation without anticoagulants

Endovenous laser ablation with short-term anticoagulant

Medical treatment

Arm Description

Endovenous laser ablation without using of any anticoagulant

Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium

45 days of subcutaneous fondaparinux sodium

Outcomes

Primary Outcome Measures

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
Major bleedings
Major bleedings according to ISTH definition

Secondary Outcome Measures

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
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
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
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
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
Major bleedings
Major bleedings according to ISTH definition
Major bleedings
Major bleedings according to ISTH definition
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria

Full Information

First Posted
July 28, 2021
Last Updated
March 22, 2023
Sponsor
National Medical Research Center for Therapy and Preventive Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05001776
Brief Title
Endovenous Laser Ablation in Acute Thrombophlebitis of the Varicose Great Saphenous Vein
Official Title
Choice of the Optimal Method for Treatment of Acute Thrombophlebitis of the Varicose Great Saphenous Vein: Comparison of Endovenous Laser Ablation and Conservative Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Medical Research Center for Therapy and Preventive Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Π 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Vein Thrombosis, Endovenous Laser Ablation
Keywords
acute thrombophlebitis, acute thrombosis, superficial vein of leg, great saphenous vein, various vein, endovenous laser ablation, fondaparinux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective single-centre open-label randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovenous laser ablation without anticoagulants
Arm Type
Active Comparator
Arm Description
Endovenous laser ablation without using of any anticoagulant
Arm Title
Endovenous laser ablation with short-term anticoagulant
Arm Type
Active Comparator
Arm Description
Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium
Arm Title
Medical treatment
Arm Type
Active Comparator
Arm Description
45 days of subcutaneous fondaparinux sodium
Intervention Type
Procedure
Intervention Name(s)
Endovenous laser ablation
Other Intervention Name(s)
Ablation of varicose vein
Intervention Description
Laser ablation of the great saphenous vein close to sapheno-femoral junction
Intervention Type
Drug
Intervention Name(s)
Fondaparinux Sodium
Other Intervention Name(s)
Anticoagulation
Intervention Description
Fondaparinux sodium for 7 days or 45 days
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
45 days
Title
Major bleedings
Description
Major bleedings according to ISTH definition
Time Frame
45 days
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
7 days
Title
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
Description
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
Time Frame
90 days
Title
Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
Description
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
Time Frame
7 days
Title
Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
Description
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
Time Frame
45 days
Title
Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
Description
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
Time Frame
90 days
Title
Major bleedings
Description
Major bleedings according to ISTH definition
Time Frame
7 days
Title
Major bleedings
Description
Major bleedings according to ISTH definition
Time Frame
90 days
Title
All bleedings
Description
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
Time Frame
7 days
Title
All bleedings
Description
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
Time Frame
45 days
Title
All bleedings
Description
All overt bleedings classified as major, clinically relevant non-major and minor
Time Frame
90 days
Title
Bleedings according to BARC criteria
Description
Overt bleedings classified with BARC criteria
Time Frame
7 days
Title
Bleedings according to BARC criteria
Description
Overt bleedings classified with BARC criteria
Time Frame
Overt bleedings classified with BARC criteria
Title
Bleedings according to BARC criteria
Description
Overt bleedings classified with BARC criteria
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Surgical intervention for superficial vein thrombosis
Description
Requirement of unplanned surgical intervention for treatment of superficial vein thrombosis
Time Frame
45 days
Title
Surgical intervention for superficial vein thrombosis
Description
Requirement of unplanned surgical intervention for treatment of superficial vein thrombosis
Time Frame
90 days
Title
Severity of pain
Description
10 cm visual analog scale of pain and 0-10 numeric pain rating score (0 - no pain, 10 - worst imaginable pain)
Time Frame
7 days
Title
Severity of pain
Description
10 cm visual analog scale of pain and 0-10 numeric pain rating score (0 - no pain, 10 - worst imaginable pain)
Time Frame
45 days
Title
Severity of pain
Description
10 cm visual analog scale of pain and 0-10 numeric pain rating score (0 - no pain, 10 - worst imaginable pain)
Time Frame
90 days
Title
Quality of life according to 36-Item Short Form Health Status Survey
Description
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
7 days
Title
Quality of life according to 36-Item Short Form Health Status Survey
Description
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
45 days
Title
Quality of life according to 36-Item Short Form Health Status Survey
Description
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
90 days
Title
Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
Description
Zero score is equivalent to no disability and a score of 10 is equivalent to maximal disability
Time Frame
7 days
Title
Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
Description
Zero score is equivalent to no disability and a score of 10 is equivalent to maximal disability
Time Frame
45 days
Title
Quality of life according to European Quality of Life Questionnaire EQ-5D-3L
Description
Zero score is equivalent to no disability and a score of 10 is equivalent to maximal disability
Time Frame
90 days
Title
Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Description
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
7 days
Title
Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Description
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
45 days
Title
Quality of life according to Chronic Venous Disease quality of life Questionnaire (CIVIQ-20)
Description
Zero score is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor S Yavelov, MD
Phone
79166059047
Email
IYavelov@gnicpm.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor S Yavelov, MD
Organizational Affiliation
National Medical Research Center for Therapy and Preventive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Medical Research Center for Therapy and Preventive Medicinel
City
Moscow
ZIP/Postal Code
10100
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor S Yavelov, MD
Phone
79166059047
Email
IYavelov@gnicpm.ru
First Name & Middle Initial & Last Name & Degree
Igor S Yavelov, MD
First Name & Middle Initial & Last Name & Degree
Konstantin A Kaperiz, MD

12. IPD Sharing Statement

Learn more about this trial

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

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