Inferior Vena Cava Filters: Analysis of… | Clinical Trial

Key information

Conditions

Deep Vein Thrombosis, Pulmonary Embolus Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

16 year–91 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

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 , who underwent retrieving of cava-filter due to the pulmonary embolism risk regression
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

Number of participants with filter implanted without the possibility of its removal due to various reasons and without its occlusion

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

Inferior Vena Cava Filters Utilization in Patients With Venous Thromboembolism: Analysis of a Database of a Tertiary Hospital

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Apr 1, 2020
Registry last updated: Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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