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

Identification of Patients at Low Risk of Recurrent Venous Thromboembolism After Stopping Anticoagulant Treatment: A Prospective Multicenter Cohort Study (Validation of the Vienna Prediction Model)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01972243
Enrollment
800
Registered
2013-10-30
Start date
2013-09-30
Completion date
2021-05-31
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

risk of recurrent

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.

Interventions

OTHERno intervention

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Design outcomes

Primary

MeasureTime frame
recurrent venous thromboembolism2 years

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026