Ongoing Registry of Treatment of Venous Thromboembolism

Pulmonary Embolism Clinical Trial

— RRT VTE  

Official title:

Russian Registry of Treatment of Venous Thromboembolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03881345
• Other study ID #: A002
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: March 1, 2036

Study information

• Verified date: March 2024
• Source: Medalp Private Surgery Clinic
• Contact: Evgeny Ilyukhin
• Phone: +79218451722
• Email: evgeny[@]ilyukhin.info
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 1, 2036
• Est. primary completion date: March 1, 2036
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• case of venous thrombosis of a limb or pulmonary embolus

Exclusion Criteria:

• no exclusion criteria

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Embolism and Thrombosis
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Pulmonary Embolism
• Thromboembolism
• Thromboses, Venous
• Thrombosis
• Thrombosis Embolism
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Anticoagulants
anticoagulation according to the main diagnosis

Procedure:
• Open surgery
removal of blood clots with open surgery
• Thrombolysis
removal of blood clots with thrombolysis
• Venous stenting
elimination of vein obstruction by stenting

Locations

Country	Name	City	State
Russian Federation	Pirogov Russian National Research Medical University	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Medalp Private Surgery Clinic	State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Veins patency	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	Postthrombotic syndrome	the presence and severity of postthrombotic syndrome on the Villalta scale	Baseline, 3 and 12 months post-intervention
Secondary	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.	Baseline, 3 and 12 months post-intervention
Secondary	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.	Baseline, 3 and 12 months post-intervention

External Links

•   Russian Phlebological Association (RPA)
•   Russian Registry of Treatment of Venous Thromboembolism (RRT VTE)