- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330170
Inferior Vena Cava Filters: Analysis of a Database
Inferior Vena Cava Filters Utilization in Patients With Venous Thromboembolism: Analysis of a Database of a Tertiary Hospital
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 117997
- The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Number of participants with embolic or thrombotic occlusion of inferior vena cava-filter
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from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Number of participants , who underwent retrieving of cava-filter due to the pulmonary embolism risk regression
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from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
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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
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Number of participants with filter implanted without the possibility of its removal due to various reasons and without its occlusion
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from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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