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
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
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
NCT ID
NCT05001776
First Posted
July 28, 2021
Last Updated
March 22, 2023
Sponsor
National Medical Research Center for Therapy and Preventive Medicine
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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