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NCT00631423 Clinical Trial

Evaluation of Patients With Vena Cava Inferior Thrombosis

Venous Thromboembolism Clinical Trial

Official title:
Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00631423
Other study ID # E 102/7
Secondary ID
Status Completed
Phase N/A
First received February 27, 2008
Last updated April 14, 2015
Start date July 2007
Est. completion date August 2014

Study information
Verified date April 2015
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.

Description:

All Patients are assessed using a standardized questionnaire and details concerning VTE risk factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date August 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- age 18-90 years

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt Frankfurt/Main Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrent venous thromboembolism 6, 12, 24 and 60 months No
Secondary All-cause mortality 6, 12, 24 and 60 months No
Secondary Post-thrombotic syndrome 24 and 60 months No
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