Evaluation of Patients With Vena Cava Inferior Thrombosis

This study is currently recruiting participants.
Verified March 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Birgit Linnemann, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00631423
First received: February 27, 2008
Last updated: March 30, 2012
Last verified: March 2012
  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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Recurrent venous thromboembolism [ Time Frame: 6, 12, 24 and 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 6, 12, 24 and 60 months ] [ Designated as safety issue: No ]
  • Post-thrombotic syndrome [ Time Frame: 24 and 60 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum


Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: August 2014
Estimated 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631423

Contacts
Contact: Birgit Linnemann, MD +49 69 6301 ext 5096 Birgit.Linnemann@kgu.de
Contact: Edelgard Lindhoff-Last, MD +49 69 6301 ext 5096 Lindhoff-Last@em.uni-frankfurt.de

Locations
Germany
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt Recruiting
Frankfurt/Main, Hessen, Germany, D-60590
Contact: Birgit Linnemann, MD    +49 69 6301 ext 5096    Birgit.Linnemann@kgu.de   
Contact: Edelgard Lindhoff-Last, MD    +49 69 6301 ext 5096    Lindhoff-Last@em.uni-frankfurt.de   
Principal Investigator: Birgit Linnemann, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Birgit Linnemann, MD Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany
  More Information

No publications provided

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
Study First Received: February 27, 2008
Last Updated: March 30, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 23, 2014