Inferior Vena Cava ThrombosisNCT00631423
Evaluation of Patients With Vena Cava Inferior Thrombosis
An observational study of Inferior Vena Cava Thrombosis and Venous Thromboembolism, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inferior Vena Cava Thrombosis, Venous Thromboembolism
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Aug 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with venous thrombosis involving the inferior cava inferior obtained from the Main-Isar-Thrombosis registry in which all patients seen for venous thromboembolism in our department are registered
Who may be able to join
- age 18-90 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, D-60590
About this study
Official title: Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis
The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.
Read the detailed description
All Patients are assessed using a standardized questionnaire and details concerning VTE risk factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with vena cava inferior thrombosis | |
| 2 | Patients with isolated lower-extremity DVT matched for gender and age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent venous thromboembolism
Measured: 6, 12, 24 and 60 months
Secondary outcomes (2)
All-cause mortality
Measured: 6, 12, 24 and 60 months
Post-thrombotic syndrome
Measured: 24 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena Cava 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgit Linnemann, Johann Wolfgang Goethe University Hospital
- Investigators
- Birgit Linnemann, MD, Principal investigator, Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631423
- Sponsor's protocol ID
- E 102/7
- Status last verified
- Apr 2015
- First submitted
- 27 Feb 2008
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course and Prognosis of Patients With Vena Cava Inferior Thrombosis
- ClinicalTrials.gov ID
- NCT00631423
- Acronym / sponsor ID
- E 102/7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Mar 2008 (estimated)
- 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.
The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.
Detailed description
All Patients are assessed using a standardized questionnaire and details concerning VTE risk factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with vena cava inferior thrombosis |
| 2 | – | –Patients with isolated lower-extremity DVT matched for gender and age |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with venous thrombosis involving the inferior cava inferior obtained from the Main-Isar-Thrombosis registry in which all patients seen for venous thromboembolism in our department are registered
Key inclusion criteria (1 listed)
- age 18-90 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent venous thromboembolism
Time frame: 6, 12, 24 and 60 months
2 secondary outcomes
All-cause mortality
Time frame: 6, 12, 24 and 60 months
Post-thrombotic syndrome
Time frame: 24 and 60 months
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 15 Apr 2015.
Related trials for Inferior Vena Cava Thrombosis
Not yet recruitingObservational study
Habitat Analysis of Tumor Thrombus for Vena Cava Wall Invasion in Renal Cell Carcinoma
Carcinoma, Renal Cell, Inferior Vena Cava Tumor Thrombus
Not yet recruitingObservational study
AngioVac Aspiration Therapy Registry
Intracardiac Thrombus, Intracardiac Mass
Active, not recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
Venous Thromboses, Venous Disease
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
Renal Cancer, Kidney Cancer
RecruitingObservational study
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion
Carcinoma, Renal Cell, Tumor Thrombus
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.
Birgit Linnemann, MD principal investigator
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany
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 Inferior Vena Cava Thrombosis and Venous Thromboembolism, run by Johann Wolfgang Goethe University Hospital 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 1 inclusion and 1 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 15 Apr 2015. 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?
Recurrent venous thromboembolism (time frame: 6, 12, 24 and 60 months). 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 15 Apr 2015.