Inferior Vena Cava Filters: Analysis of a Database

Deep Vein Thrombosis, Pulmonary Embolus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330170
• Other study ID #: 180
• Status: Completed
• Start date: January 13, 2016
• Est. completion date: March 28, 2020

Study information

• Verified date: April 2020
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2399
• Est. completion date: March 28, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 91 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deep Vein Thrombosis, Pulmonary Embolus
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Russian Federation	The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with occlusion of inferior vena cava-filter	Number of participants with embolic or thrombotic occlusion of inferior vena cava-filter	from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Secondary	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	from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks
Secondary	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	from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks