Clinical trial NCT04330170: Inferior Vena Cava Filters: Analysis of a Database
Official title: Inferior Vena Cava Filters Utilization in Patients With Venous Thromboembolism: Analysis of a Database of a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis, Pulmonary Embolus
Keywords: deep vein thrombosis
inferior vena cava-filter
pulmonary embolism
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 2399
Sex: ALL
Minimum age (years): 16
Maximum age (years): 91
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with occlusion of inferior vena cava-filter
timeFrame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Secondary outcomes:
measure: Number of participants who have undergone cava-filter removal
timeFrame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
measure: Number of participants with implanted cava filter in whom the filter remained intact
timeFrame: from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Study officials:
References: