Evaluation of Patients With Vena Cava Inferior Thrombosis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014