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

Sponsor

Medical University of Vienna (Other)

Overall Status

Unknown status

CT.gov ID

NCT01972243

Collaborator

(none)

500

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Other: no intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
venous thromboembolism	Other: no intervention

Arm

Intervention/Treatment

venous thromboembolism

Other: no intervention

Outcome Measures

Primary Outcome Measures

recurrent venous thromboembolism [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sabine Eichinger, MD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01972243

Other Study ID Numbers:

KLI316

First Posted:

Oct 30, 2013

Last Update Posted:

Oct 30, 2013

Last Verified:

Oct 1, 2013

Keywords provided by Sabine Eichinger, MD, Medical University of Vienna

risk of recurrent

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Study Results

No Results Posted as of Oct 30, 2013