Substudy - Evaluation of Patients With Iliac Vein Thrombosis

NCT03148548 | Completed

• 1 other identifier: ILIACA-PTS
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Iliac Vein Thrombosis

Keywords

VTE; thrombophilia screening; patients; risk factors; post-thrombotic syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Distribution of gender in Iliofemoral thrombosis

  since 1996

• Distribution of affected side in Iliofemoral thrombosis

  since 1996

• Disease-specific quality of life instrument for use in venous diseases of the leg (VEINES-QOL)

  1 year

• Incidence of venous claudication

  1 year

Study Arms (2)

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

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

Interventions

thrombophilia screening GENETIC

genetic Evaluation of Factor-V-Leiden, Factor-II\_G20210A Mutation;

Patients with ilifermoral thrombosis with rekanalisation; Patients with iliofermoral thrombosis without rekanalisation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead

Study Sites (1)

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blodd, serum

MeSH Terms

Conditions

Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Edelgard Lindhoff-Last, Prof.

  Cardioangiologisches Centrum Bethanien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: May 11, 2017
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)