Deep Vein Thrombosis, Pulmonary EmbolusNCT04330170
Inferior Vena Cava Filters: Analysis of a Database
An observational study of Deep Vein Thrombosis, Pulmonary Embolus, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
In this study a retrospective analysis of patients database was performed, who underwent treatment for deep vein thrombosis in tertiary hospital by using inferior vena cava-filters Read more about this study
- Who is it for?
- Ages 16 to 91 years
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolus
- How many people
- 2,399 participants
- Where
- 1 siteRussia
- Study dates
- 13 Jan 2016to 28 Mar 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 16 to 91 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 2399 patients who were either hospitalized with venous thromboembolism or diagnosed with venous thromboembolism during hospital stay in 2016-2017. Of them there were 1173 male (48,9%) and 1226 female (51,1%) patients with average age of 62,4 ± 15,2 (min - 16, max - 96).
Who may be able to join
- Anticoagulation therapy contraindicated
- Anticoagulation therapy ineffective
- High pulmonary embolism risk (floating thrombus in proximal location)
- Deep vein thrombosis/pulmonary embolism together with high pulmonary hypertension(>50 mm.Hg)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Russia1 site
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, 117997
About this study
Official title: Inferior Vena Cava Filters Utilization in Patients With Venous Thromboembolism: Analysis of a Database of a Tertiary Hospital
In this study a retrospective analysis of patients database was performed, who underwent treatment for deep vein thrombosis in tertiary hospital by using inferior vena cava-filters
Read the detailed description
The aim of this research was to assess the cava-filter implantation frequency in a tertiary hospital with venous thromboembolism treatment center.
A retrospective analysis of patient's database was performed, who underwent treatment in the tertiary clinic between 2016 - 2017. In total, 2399 patients with venous thromboembolism were hospitalized, 442 cava-filters were implanted (239 in 2016 and 203 in 2017), which accounted for 18.4% of patients with venous thromboembolism. Removable cava-filters models were used in most cases (98.8%). Contraindications for anticoagulation were reason for cava-filters implantation in 119 (26.9%) cases, and in 184 patients (41.6%) cava-filters were implanted due to the inefficiency of anticoagulation. 38 (8.6%) patients with deep vein thrombosis (DVT) and pulmonary embolism had pulmonary hypertension of the 2nd to 3rd degree, which caused the implantation of cava-filters .
The occlusion of the inferior vena cava and cava-filters verified in 116 (26.9%) patients after cava-filters implantation, based on repeated ultrasound. The overall mortality rate in the group of patients with venous thromboembolism was 0.25% (6 patients), 5 of them (1.1%) underwent cava-filters implantation. The cause of all lethal outcomes was the progression of the underlying disease. During the next hospitalization 29 (6.5%) of implanted filters were endovascularly removed.
There are 18.4% of patients with venous thromboembolism undergoing cava-filters implantation for various reasons in a tertiary hospital. At the same time, occlusion of the inferior vena cava and cava-filters in the early post implantation period is observed in 26.9%. However, without clear criteria for the differentiation of cava-filters embolism from its thrombosis, we cannot assess whether this was a complication, or if the cava-filters completed its task by preventing pulmonary embolism. Thus, the validity of implanting cava filters question in terms of efficiency and safety remains unanswered, which poses the task for deep study of this problem and thorough analysis of the indications for the cava-filters implantation.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolus
- Keywords
- deep vein thrombosis, inferior vena cava-filter, pulmonary embolism
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with occlusion of inferior vena cava-filter
Number of participants with embolic or thrombotic occlusion of inferior vena cava-filter
Measured: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Secondary outcomes (2)
Number of participants who have undergone cava-filter removal
Number of participants , who underwent retrieving of cava-filter due to the pulmonary embolism risk regression
Measured: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Number of participants with implanted cava filter in whom the filter remained intact
Number of participants with filter implanted without the possibility of its removal due to various reasons and without its occlusion
Measured: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start13 Jan 2016
- Primary completion28 Mar 2020
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis, Pulmonary EmbolusStudies 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
- Retrospective
- Enrolment
- 2,399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Zolotukhin, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330170
- Sponsor's protocol ID
- 180
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2020
- Last updated
- 6 Apr 2020
- Results posted
- 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 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Filters Utilization in Patients With Venous Thromboembolism: Analysis of a Database of a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT04330170
- Acronym / sponsor ID
- 180
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolus
- Keywords
- deep vein thrombosis, inferior vena cava-filter, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,399 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 1 Apr 2020 (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.
In this study a retrospective analysis of patients database was performed, who underwent treatment for deep vein thrombosis in tertiary hospital by using inferior vena cava-filters
Detailed description
The aim of this research was to assess the cava-filter implantation frequency in a tertiary hospital with venous thromboembolism treatment center.
A retrospective analysis of patient's database was performed, who underwent treatment in the tertiary clinic between 2016 - 2017. In total, 2399 patients with venous thromboembolism were hospitalized, 442 cava-filters were implanted (239 in 2016 and 203 in 2017), which accounted for 18.4% of patients with venous thromboembolism. Removable cava-filters models were used in most cases (98.8%). Contraindications for anticoagulation were reason for cava-filters implantation in 119 (26.9%) cases, and in 184 patients (41.6%) cava-filters were implanted due to the inefficiency of anticoagulation. 38 (8.6%) patients with deep vein thrombosis (DVT) and pulmonary embolism had pulmonary hypertension of the 2nd to 3rd degree, which caused the implantation of cava-filters .
The occlusion of the inferior vena cava and cava-filters verified in 116 (26.9%) patients after cava-filters implantation, based on repeated ultrasound. The overall mortality rate in the group of patients with venous thromboembolism was 0.25% (6 patients), 5 of them (1.1%) underwent cava-filters implantation. The cause of all lethal outcomes was the progression of the underlying disease. During the next hospitalization 29 (6.5%) of implanted filters were endovascularly removed.
There are 18.4% of patients with venous thromboembolism undergoing cava-filters implantation for various reasons in a tertiary hospital. At the same time, occlusion of the inferior vena cava and cava-filters in the early post implantation period is observed in 26.9%. However, without clear criteria for the differentiation of cava-filters embolism from its thrombosis, we cannot assess whether this was a complication, or if the cava-filters completed its task by preventing pulmonary embolism. Thus, the validity of implanting cava filters question in terms of efficiency and safety remains unanswered, which poses the task for deep study of this problem and thorough analysis of the indications for the cava-filters implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2399 patients who were either hospitalized with venous thromboembolism or diagnosed with venous thromboembolism during hospital stay in 2016-2017. Of them there were 1173 male (48,9%) and 1226 female (51,1%) patients with average age of 62,4 ± 15,2 (min - 16, max - 96).
Key inclusion criteria (4 listed)
- Anticoagulation therapy contraindicated
- Anticoagulation therapy ineffective
- High pulmonary embolism risk (floating thrombus in proximal location)
- Deep vein thrombosis/pulmonary embolism together with high pulmonary hypertension(>50 mm.Hg)
Key exclusion criteria (0 listed)
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
Number of participants with occlusion of inferior vena cava-filter
Time frame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Number of participants with embolic or thrombotic occlusion of inferior vena cava-filter
2 secondary outcomes
Number of participants who have undergone cava-filter removal
Time frame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Number of participants with implanted cava filter in whom the filter remained intact
Time frame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
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 6 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Deep Vein Thrombosis, Pulmonary Embolus, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 4 inclusion and 0 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 6 Apr 2020. 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 Russia. 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?
Number of participants with occlusion of inferior vena cava-filter (time frame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks). 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 6 Apr 2020.