Substudy - Evaluation of Patients With Iliac Vein Thrombosis

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Iliac Vein Thrombosis

Intervention / Treatment
-----------------
* Genetic: thrombophilia screening


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with iliofermoral thrombosis without rekanalisation<br>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<br>* genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;<br>|
| Patients with ilifermoral thrombosis with rekanalisation<br>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<br>* genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of postthrombotic Syndrome after 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 | Distribution of gender (man or woman) | since 1996 | 
| Distribution of affected side in Iliofemoral thrombosis | 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) | A quality of life questionaire comprises 25 items that quantify disease effect on quality of life | 1 year | 
| Incidence of venous claudication | Walking distance on treadmill | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VTE, thrombophilia screening, patients, risk factors, post-thrombotic syndrome