Iliac Vein ThrombosisNCT03148548
Substudy - Evaluation of Patients With Iliac Vein Thrombosis
An observational study of Iliac Vein Thrombosis, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iliac Vein Thrombosis
- What is being tested?
- thrombophilia screening
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Jan 2018
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with previous iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT)
Who may be able to join
- >18 years
- subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996
Who cannot join
- <18 years
- > 80 years
- surface or deep vein thrombosis without affection of pelvis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Hesse, 60389
About this study
Official title: 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.
- Conditions
- Iliac Vein Thrombosis
- Being tested
- thrombophilia screening
- Keywords
- VTE, thrombophilia screening, patients, risk factors, post-thrombotic syndrome
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombophilia screeningGenetic
genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Genetic: thrombophilia screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis
The incidence and severity of postthrombotic Syndrome will be measured by te VILALLTA-Score
Measured: up to 20 years after occurrence of iliofemoral thrombosis
Secondary outcomes (4)
Distribution of gender in Iliofemoral thrombosis
Distribution of gender (man or woman)
Measured: since 1996
Distribution of affected side in Iliofemoral thrombosis
distribution of affected side (left or right side)
Measured: 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
Measured: 1 year
Incidence of venous claudication
Walking distance on treadmill
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startNov 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edelgard Lindhoff-Last, Prof., Principal investigator, Cardioangiologisches Centrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148548
- Sponsor's protocol ID
- ILIACA-PTS
- Status last verified
- Oct 2019
- First submitted
- 7 Mar 2017
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iliofemoral Thrombosis and Postthrombotic Syndrome: Registration and Analysis Within the Frankfurt Thrombophilia Registry
- ClinicalTrials.gov ID
- NCT03148548
- Acronym / sponsor ID
- ILIACA-PTS
- Conditions
- Iliac Vein Thrombosis
- Keywords
- VTE, thrombophilia screening, patients, risk factors, post-thrombotic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with iliofermoral thrombosis without rekanalisation | – | Genetic: thrombophilia screeningsubjects 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 | – | Genetic: thrombophilia screeningsubjects 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with previous iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT)
Key inclusion criteria (2 listed)
- >18 years
- subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996
Key exclusion criteria (3 listed)
- <18 years
- > 80 years
- surface or deep vein thrombosis without affection of pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombophilia screeninggenetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation; | Genetic | Patients with ilifermoral thrombosis with rekanalisation, Patients with iliofermoral thrombosis without rekanalisation |
Primary outcome
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
4 secondary outcomes
Distribution of gender in Iliofemoral thrombosis
Time frame: since 1996
Distribution of affected side in Iliofemoral thrombosis
Time frame: since 1996
Disease-specific quality of life instrument for use in venous diseases of the leg (VEINES-QOL)
Time frame: 1 year
Incidence of venous claudication
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Iliac Vein Thrombosis
Recruiting
Outcomes of Iliac Vein Stenting With Dedicated Venous Stents in Treatment of Chronic Post-thrombotic Venous Ulcers
Vascular, DVT - Deep Vein Thrombosis
Active, not recruiting
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Deep Vein Thrombosis, Venous Stasis
Recruiting
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Deep Vein Thrombosis, Iliac Vein Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edelgard Lindhoff-Last, Prof. principal investigator
Cardioangiologisches Centrum Bethanien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Vein Thrombosis, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis (time frame: up to 20 years after occurrence of iliofemoral thrombosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.