Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model

Completed

• Conditions: Venous Thromboembolism
• Interventions: Other: no intervention

• Registration Number: NCT01972243
• Lead Sponsor: Medical University of Vienna

Brief Summary

Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite anticoagulation is recommended, but confers a considerable bleeding risk. It is important to identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and who will not benefit from long term anticoagulation. By use of a scoring model (Vienna Prediction Model), patients can be stratified according to their recurrence risk based on their sex, location of VTE and D-Dimer. Before implementation in routine care, an independent validation is required. Patients with unprovoked VTE will stop anticoagulation after 3-7 months and the recurrence risk will be estimated by use of the Vienna Prediction Model. Low risk patients with a score of \<180 will be included and will be left untreated. Patients with a high score will not be included and their management will follow current guidelines. Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-10-30
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Age > 18 years symptomatic uni- or bilateral proximal (including the trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein) or distal DVT of the leg and/or symptomatic PE.

VTE not provoked by one of the following temporary risk factors: surgery, trauma,pregnancy, cancer, immobilisation.

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Exclusion Criteria

History of previous VTE; anticoagulation for longer than 6 months; reasons for long-term anticoagulation other than VTE; poor patient compliance; no consent to participate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
venous thromboembolism	no intervention	-

Primary Outcome Measures

Name	Time	Method
recurrent venous thromboembolism	2 years

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria