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

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ClinicalTrials.gov Identifier: NCT01972243
Recruitment Status : Unknown
Verified October 2013 by Sabine Eichinger, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Sabine Eichinger, 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.

Condition or disease Intervention/treatment
Venous Thromboembolism Other: no intervention

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Study Type : Observational
Estimated 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 : September 2013
Estimated Primary Completion Date : December 2016

Group/Cohort Intervention/treatment
venous thromboembolism Other: no intervention



Primary Outcome Measures :
  1. recurrent venous thromboembolism [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
first unprovoked deep vein thrombosis or pulmonary embolism
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972243


Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Sabine Eichinger       sabine.eichinger@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Sabine Eichinger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01972243     History of Changes
Other Study ID Numbers: KLI316
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Sabine Eichinger, Medical University of Vienna:
risk of recurrent

Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases