Venous Thromboembolic DiseaseNCT04846725
Predictors of Attempted Inferior Vena Cava Filters Retrieval.
An observational study of Venous Thromboembolic Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolic Disease
- What is being tested?
- Data collection
- How many people
- 356 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019 will be included.
Who may be able to join
- patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal.
All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.
- Conditions
- Venous Thromboembolic Disease
- Being tested
- Data collection
- Keywords
- Inferior vena cava filter, inferior vena cava filter retrieval, inferior vena cava filter complications, deep vein thrombosis (DVT), pulmonary embolism, venous thromboembolism event (VTE)
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collect in medical records :
- Filter's retrieval rate
- Complications of vena cava filters
- Predictive factors of attempted inferior vena cava filters retrieval: age, the distance between the patient's home and the hospital, the indication or not given by the therapeutic medicine department, patients referred by external structures, patients whose filter was installed during the medical on-call period, the absence of a written request for filter placement, the presence of active neoplasia at the time of filter placement, a peri-surgical context.
| Study group | Role | What they receive |
|---|---|---|
| Retrievable Inferior Vena Cava Filters (IVCF) | The population study includes patients with a Retrievable Inferior Vena Cava Filters (IVCF) inserted between April 2012 and November 2019. Follow up data is collected up to July 2020. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter's retrieval rate (%)
Collect in medical records.
Measured: Month: 2
Secondary outcomes (2)
Predictive factors of attempted inferior vena cava filters retrieval
Collect in medical records.
Measured: Month: 2
Adverse event of vena cava filters
Collect in medical records.
Measured: Month: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Oct 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Grange, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846725
- Sponsor's protocol ID
- IRBN372021/CHUSTE
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Attempted Inferior Vena Cava Filters Retrieval.
- ClinicalTrials.gov ID
- NCT04846725
- Acronym / sponsor ID
- IRBN372021/CHUSTE
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Inferior vena cava filter, inferior vena cava filter retrieval, inferior vena cava filter complications, deep vein thrombosis (DVT), pulmonary embolism, venous thromboembolism event (VTE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 15 Apr 2021 (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.
The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal.
All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrievable Inferior Vena Cava Filters (IVCF) | – | Other: Data collectionThe population study includes patients with a Retrievable Inferior Vena Cava Filters (IVCF) inserted between April 2012 and November 2019. Follow up data is collected up to July 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019 will be included.
Key inclusion criteria (1 listed)
- patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionCollect in medical records : * Filter's retrieval rate * Complications of vena cava filters * Predictive factors of attempted inferior vena cava filters retrieval: age, the distance between the patient's home and the hospital, the indication or not given by the therapeutic medicine department, patients referred by external structures, patients whose filter was installed during the medical on-call period, the absence of a written request for filter placement, the presence of active neoplasia at the time of filter placement, a peri-surgical context. | Other | Retrievable Inferior Vena Cava Filters (IVCF) |
Primary outcome
Filter's retrieval rate (%)
Time frame: Month: 2
Collect in medical records.
2 secondary outcomes
Predictive factors of attempted inferior vena cava filters retrieval
Time frame: Month: 2
Adverse event of vena cava filters
Time frame: Month: 2
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 2021.
- Individual participant dataSharing planned: No
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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.
Sylvain Grange, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Venous Thromboembolic Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2021. 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 France. 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?
Filter's retrieval rate (%) (time frame: Month: 2). 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 2021.