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Evaluation of Patients With Vena Cava Inferior Thrombosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631423
First Posted: March 7, 2008
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Birgit Linnemann, Johann Wolfgang Goethe University Hospitals
  Purpose
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.

Condition
Inferior Vena Cava Thrombosis Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis

Resource links provided by NLM:


Further study details as provided by Birgit Linnemann, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Recurrent venous thromboembolism [ Time Frame: 6, 12, 24 and 60 months ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 6, 12, 24 and 60 months ]
  • Post-thrombotic syndrome [ Time Frame: 24 and 60 months ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum

Estimated Enrollment: 120
Study Start Date: July 2007
Study Completion Date: August 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with vena cava inferior thrombosis
2
Patients with isolated lower-extremity DVT matched for gender and age

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with venous thrombosis involving the inferior cava inferior obtained from the Main-Isar-Thrombosis registry in which all patients seen for venous thromboembolism in our department are registered
Criteria

Inclusion Criteria:

  • age 18-90 years

Exclusion Criteria:

  Contacts and Locations
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): NCT00631423


Locations
Germany
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt
Frankfurt/Main, Hessen, Germany, D-60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Birgit Linnemann, MD Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany
  More Information

Responsible Party: Birgit Linnemann, M.D., Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00631423     History of Changes
Other Study ID Numbers: E 102/7
First Submitted: February 27, 2008
First Posted: March 7, 2008
Last Update Posted: April 15, 2015
Last Verified: April 2015

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