Deep Vein ThrombosisRRT VTENCT03881345
Ongoing Registry of Treatment of Venous Thromboembolism
An observational study of Deep Vein Thrombosis and Thromboses, Venous, run by Medalp Private Surgery Clinic at 1 site in Russia.
Trial summary
Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Thromboses, Venous, Thrombosis Embolism
- What is being tested?
- Anticoagulants, Open surgery and Thrombolysis
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2019to 1 Mar 2036
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients undergoing any kind of treatment for venous thromboembolism
Who may be able to join
- case of venous thrombosis of a limb or pulmonary embolus
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Pirogov Russian National Research Medical University
Moscow, Moscow, 190000
Yury Stoyko, MD, PhD
About this study
Official title: Russian Registry of Treatment of Venous Thromboembolism
Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.
Read the detailed description
Data of patients with VTE treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.
There is planned to conduct prospective randomized, cohort and observational studies on the site of register
- Conditions
- Deep Vein Thrombosis, Thromboses, Venous, Thrombosis Embolism, Postthrombotic Syndrome, Pulmonary Embolism
- Being tested
- Anticoagulants, Open surgery, Thrombolysis, Venous stenting
- Medical subject headings
- Venous Thrombosis, Embolism and Thrombosis, Postthrombotic Syndrome, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulantsDrug
anticoagulation according to the main diagnosis
Open surgeryProcedure or surgery
removal of blood clots with open surgery
ThrombolysisProcedure or surgery
removal of blood clots with thrombolysis
Venous stentingProcedure or surgery
elimination of vein obstruction by stenting
What is being measured
The primary outcome is the main question the study is designed to answer.
Veins patency
Change in patency target veins assessed by duplex ultrasonography in different follow up periods due to different treatment methods
Measured: Baseline, 3 and 12 months post-intervention
Secondary outcomes (3)
Postthrombotic syndrome
the presence and severity of postthrombotic syndrome on the Villalta scale
Measured: Baseline, 3 and 12 months post-intervention
QoL SF-36
Change in Quality of Life (QoL), assessed by "Short form 36" health survey (SF-36). Total scale range: from 0 to 800. SF-36 consists of 8 subscales. Each subscale range: 0 - 100. Subscales are combined using a special algorithm described in the instructions for the SF-36. For total scale the higher value represent the worse QoL.
Measured: Baseline, 3 and 12 months post-intervention
QoL AVVQ
Change in Quality of Life (QoL), assessed by "Aberdeen Varicose Vein Questionnaire" (AVVQ). The AVVQ is a disease-specific QoL questionnaire aimed at venous disease. Total scale range: from 0 to 100, where the higher score represent worse QoL.
Measured: Baseline, 3 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Mar 2036 (estimated)
- Study completion1 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medalp Private Surgery Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Responsible party
- Principal investigator, Evgeny Ilyukhin, Medalp Private Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881345
- Sponsor's protocol ID
- A002
- Acronym
- RRT VTE
- Status last verified
- May 2025
- First submitted
- 17 Mar 2019
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian Registry of Treatment of Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT03881345
- Acronym / sponsor ID
- RRT VTE / A002
- Conditions
- Deep Vein Thrombosis, Thromboses, Venous, Thrombosis Embolism, Postthrombotic Syndrome, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medalp Private Surgery ClinicUniversity, hospital or other
- Collaborators
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2036 (estimated)
- Study completion
- 1 Mar 2036 (estimated)
- First posted
- 19 Mar 2019 (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.
Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.
Detailed description
Data of patients with VTE treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.
There is planned to conduct prospective randomized, cohort and observational studies on the site of register
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing any kind of treatment for venous thromboembolism
Key inclusion criteria (1 listed)
- case of venous thrombosis of a limb or pulmonary embolus
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| Anticoagulantsanticoagulation according to the main diagnosis | Drug | – |
| Open surgeryremoval of blood clots with open surgery | Procedure or surgery | – |
| Thrombolysisremoval of blood clots with thrombolysis | Procedure or surgery | – |
| Venous stentingelimination of vein obstruction by stenting | Procedure or surgery | – |
Primary outcome
Veins patency
Time frame: Baseline, 3 and 12 months post-intervention
Change in patency target veins assessed by duplex ultrasonography in different follow up periods due to different treatment methods
3 secondary outcomes
Postthrombotic syndrome
Time frame: Baseline, 3 and 12 months post-intervention
QoL SF-36
Time frame: Baseline, 3 and 12 months post-intervention
QoL AVVQ
Time frame: Baseline, 3 and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Russian Registry of Treatment of Venous Thromboembolism (RRT VTE)Link provided by the sponsor.
- Russian Phlebological Association (RPA)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis and Thromboses, Venous, run by Medalp Private Surgery Clinic 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Ilyukhin (+79218451722, evgeny@ilyukhin.info), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veins patency (time frame: Baseline, 3 and 12 months post-intervention). 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 8 May 2025.