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Completed

NCT Number: NCT03148548

Substudy - Evaluation of Patients With Iliac Vein Thrombosis

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.

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Key information

Conditions

Iliac Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Postthrombotic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thrombophilia screening

Genetic

genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;

Primary outcomes

  1. 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

Secondary outcomes

  1. Distribution of gender in Iliofemoral thrombosis

    Time frame: since 1996

    Distribution of gender (man or woman)

  2. Distribution of affected side in Iliofemoral thrombosis

    Time frame: since 1996

    distribution of affected side (left or right side)

  3. 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

  4. Incidence of venous claudication

    Time frame: 1 year

    Walking distance on treadmill

Sponsors and collaborators

Lead sponsor

Cardioangiologisches Centrum Bethanien

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 11, 2017
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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