Evaluation of Patients With Vena Cava Inferior Thrombosis
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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 |
- Recurrent venous thromboembolism [ Time Frame: 6, 12, 24 and 60 months ] [ Designated as safety issue: No ]
- 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 |
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
Inclusion Criteria:
- age 18-90 years
Exclusion Criteria:
- none
Contacts and Locations| 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 |
| 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 | |
| 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 May 22, 2013