Substudy - Evaluation of Patients With Iliac Vein Thrombosis

October 24, 2019 updated by: Cardioangiologisches Centrum Bethanien

Iliofemoral Thrombosis and Postthrombotic Syndrome: Registration and Analysis Within the Frankfurt Thrombophilia Registry

Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry. Using standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening of thrombophilic disorders were additionally entered into the database.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

85

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, 60389
        • Cardioangiologisches Centrum Bethanien

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with previous iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT)

Description

Inclusion Criteria:

  • >18 years
  • subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996

Exclusion Criteria:

  • <18 years
  • > 80 years
  • surface or deep vein thrombosis without affection of pelvis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with iliofermoral thrombosis without rekanalisation
subjects with proven iliofemoral thrombosis (V. cava-aplasia, pelvic vein thrombosis, VTE) which was proven by objective methods such as Duplex sonography, CT/MRT, phlebography and who did not undergo recanalisation
Genetic: thrombophilia screening
genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;
Patients with ilifermoral thrombosis with rekanalisation
subjects with proven iliofemoral thrombosis (V. cava-aplasia, pelvic vein thrombosis, VTE) which was proven by objective methods such as Duplex sonography, CT/MRT, phlebography and who did undergo recanalisation
Genetic: thrombophilia screening
genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis
Time Frame: up to 20 years after occurrence of iliofemoral thrombosis
The incidence and severity of postthrombotic Syndrome will be measured by te VILALLTA-Score
up to 20 years after occurrence of iliofemoral thrombosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of gender in Iliofemoral thrombosis
Time Frame: since 1996
Distribution of gender (man or woman)
since 1996
Distribution of affected side in Iliofemoral thrombosis
Time Frame: since 1996
distribution of affected side (left or right side)
since 1996
Disease-specific quality of life instrument for use in venous diseases of the leg (VEINES-QOL)
Time Frame: 1 year
A quality of life questionaire comprises 25 items that quantify disease effect on quality of life
1 year
Incidence of venous claudication
Time Frame: 1 year
Walking distance on treadmill
1 year

Collaborators and Investigators

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

Sponsor

Cardioangiologisches Centrum Bethanien

Investigators

  • Principal Investigator: Edelgard Lindhoff-Last, Prof., Cardioangiologisches Centrum Bethanien

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 (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILIACA-PTS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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