Substudy - Evaluation of Patients With Iliac Vein Thrombosis

Completed

• Conditions: Iliac Vein Thrombosis
• Interventions: Genetic: thrombophilia screening

• Registration Number: NCT03148548
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with iliofermoral thrombosis without rekanalisation	thrombophilia screening	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
Patients with ilifermoral thrombosis with rekanalisation	thrombophilia screening	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

Primary Outcome Measures

Name	Time	Method
Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis	up to 20 years after occurrence of iliofemoral thrombosis	The incidence and severity of postthrombotic Syndrome will be measured by te VILALLTA-Score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt/Main, Hessen, Germany