Superficial Vein ThrombosisPhase 4NCT05001776
Endovenous Laser Ablation in Acute Thrombophlebitis of the Varicose Great Saphenous Vein
A Phase 4 study testing Endovenous laser ablation and Fondaparinux Sodium in people with Superficial Vein Thrombosis and Endovenous Laser Ablation, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Vein Thrombosis, Endovenous Laser Ablation
- What is being tested?
- Endovenous laser ablation and Fondaparinux Sodium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteRussia
- Study dates
- 16 Aug 2021to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 40Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Center for Therapy and Preventive Medicinel
Moscow, 10100
About this study
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
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.
Read the 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.
- Being tested
- Endovenous laser ablation, Fondaparinux Sodium
- Keywords
- acute thrombophlebitis, acute thrombosis, superficial vein of leg, great saphenous vein, various vein, endovenous laser ablation, fondaparinux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous laser ablationProcedure or surgery
Also called Ablation of varicose vein
Laser ablation of the great saphenous vein close to sapheno-femoral junction
Fondaparinux SodiumDrug
Also called Anticoagulation
Fondaparinux sodium for 7 days or 45 days
| Study group | Role | What they receive |
|---|---|---|
| Endovenous laser ablation without anticoagulants | Active comparator | Endovenous laser ablation without using of any anticoagulant Receives: Procedure: Endovenous laser ablation |
| Endovenous laser ablation with short-term anticoagulant | Active comparator | Endovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium Receives: Procedure: Endovenous laser ablation; Drug: Fondaparinux Sodium |
| Medical treatment | Active comparator | 45 days of subcutaneous fondaparinux sodium Receives: Drug: Fondaparinux Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 days
Major bleedings
Major bleedings according to ISTH definition
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days
Major bleedings
Major bleedings according to ISTH definition
Measured: 7 days
Major bleedings
Major bleedings according to ISTH definition
Measured: 90 days
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
Measured: 7 days
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor according to ISTH criteria
Measured: 45 days
All bleedings
All overt bleedings classified as major, clinically relevant non-major and minor
Measured: 90 days
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Measured: 7 days
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Measured: Overt bleedings classified with BARC criteria
Bleedings according to BARC criteria
Overt bleedings classified with BARC criteria
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start16 Aug 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective single-centre open-label randomized
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Igor S Yavelov, MD, Principal investigator, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001776
- Sponsor's protocol ID
- 05-06/21
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05001776
- Acronym / sponsor ID
- 05-06/21
- Keywords
- acute thrombophlebitis, acute thrombosis, superficial vein of leg, great saphenous vein, various vein, endovenous laser ablation, fondaparinux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective single-centre open-label randomized
| Arm | Type | Receives |
|---|---|---|
| Endovenous laser ablation without anticoagulants | Active comparator | Procedure: Endovenous laser ablationEndovenous laser ablation without using of any anticoagulant |
| Endovenous laser ablation with short-term anticoagulant | Active comparator | Procedure: Endovenous laser ablation, Drug: Fondaparinux SodiumEndovenous laser ablation and subsequent 7 days of subcutaneous fondaparinux sodium |
| Medical treatment | Active comparator | Drug: Fondaparinux Sodium45 days of subcutaneous fondaparinux sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (40 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovenous laser ablationAlso: Ablation of varicose veinLaser ablation of the great saphenous vein close to sapheno-femoral junction | Procedure or surgery | Endovenous laser ablation with short-term anticoagulant, Endovenous laser ablation without anticoagulants |
| Fondaparinux SodiumAlso: AnticoagulationFondaparinux sodium for 7 days or 45 days | Drug | Endovenous laser ablation with short-term anticoagulant, Medical treatment |
Primary outcome
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
Time frame: 45 days
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
Time frame: 45 days
Major bleedings according to ISTH definition
13 secondary outcomes
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
Time frame: 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
Time frame: 90 days
Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
Time frame: 7 days
Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
Time frame: 45 days
Composite of death, symptomatic deep vein thrombosis, symptomatic pulmonary embolism, symptomatic superficial vein thrombosis extension or symptomatic superficial vein thrombosis recurrence
Time frame: 90 days
Major bleedings
Time frame: 7 days
Major bleedings
Time frame: 90 days
All bleedings
Time frame: 7 days
All bleedings
Time frame: 45 days
All bleedings
Time frame: 90 days
Bleedings according to BARC criteria
Time frame: 7 days
Bleedings according to BARC criteria
Time frame: Overt bleedings classified with BARC criteria
Bleedings according to BARC criteria
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor S Yavelov, MD principal investigator
National Medical Research Center for Therapy and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endovenous laser ablation and Fondaparinux Sodium in people with Superficial Vein Thrombosis and Endovenous Laser Ablation, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.