Ongoing Registry of Treatment of Venous Thromboembolism

Recruiting

• Conditions: Thromboses, Venous; Deep Vein Thrombosis; Pulmonary Embolism; Thrombosis Embolism; Postthrombotic Syndrome

• Registration Number: NCT03881345
• Lead Sponsor: Medalp Private Surgery Clinic

Brief Summary

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 Timeline

• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-19
• Study Start: 2019-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2036-03-01
• Study Completion: 2036-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• case of venous thrombosis of a limb or pulmonary embolus

Exclusion Criteria

• no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Veins patency	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

Secondary Outcome Measures

Name	Time	Method
QoL SF-36	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.
Postthrombotic syndrome	Baseline, 3 and 12 months post-intervention	the presence and severity of postthrombotic syndrome on the Villalta scale
QoL AVVQ	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.

Trial Locations

Locations (1)

Pirogov Russian National Research Medical University; 🇷🇺 Moscow, Russian Federation