Evaluation of Patients With Vena Cava Inferior Thrombosis

April 14, 2015 updated by: Birgit Linnemann, Johann Wolfgang Goethe University Hospital

Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Hessen
  - Frankfurt/Main, Hessen, Germany, D-60590
    - Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

age 18-90 years

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Patients with vena cava inferior thrombosis
2 Patients with isolated lower-extremity DVT matched for gender and age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent venous thromboembolism Time Frame: 6, 12, 24 and 60 months	6, 12, 24 and 60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality Time Frame: 6, 12, 24 and 60 months	6, 12, 24 and 60 months
Post-thrombotic syndrome Time Frame: 24 and 60 months	24 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria