Ongoing Registry of Treatment of Venous Thromboembolism (RRT VTE)

March 11, 2024 updated by: Evgeny Ilyukhin, Medalp Private Surgery Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 190000
        • Recruiting
        • Pirogov Russian National Research Medical University
        • Contact:
          • Yury Stoyko, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing any kind of treatment for venous thromboembolism

Description

Inclusion Criteria:

  • case of venous thrombosis of a limb or pulmonary embolus

Exclusion Criteria:

  • no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 and 12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postthrombotic syndrome
Time Frame: Baseline, 3 and 12 months post-intervention
the presence and severity of postthrombotic syndrome on the Villalta scale
Baseline, 3 and 12 months post-intervention
QoL SF-36
Time Frame: Baseline, 3 and 12 months post-intervention
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.
Baseline, 3 and 12 months post-intervention
QoL AVVQ
Time Frame: Baseline, 3 and 12 months post-intervention
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.
Baseline, 3 and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medalp Private Surgery Clinic

Collaborators

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Estimated)

March 1, 2036

Study Completion (Estimated)

March 1, 2036

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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