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临床试验/NCT04330170
NCT04330170已完成不适用

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

Pirogov Russian National Research Medical University1 个研究点 分布在 1 个国家目标入组 2,399 人开始时间: 2016年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,399
试验地点
1
主要终点
Number of participants with occlusion of inferior vena cava-filter

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 91 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

结局指标

主要结局

Number of participants with occlusion of inferior vena cava-filter

时间窗: 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

次要结局

  • Number of participants with implanted cava filter in whom the filter remained intact(from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks)
  • Number of participants who have undergone cava-filter removal(from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks)

研究者

发起方
Pirogov Russian National Research Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Igor Zolotukhin

Professor of Surgery, Pirogov RNRMU, Zolotukhin Igor Anatolievich

Pirogov Russian National Research Medical University

研究点 (1)

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