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临床试验/NCT07473284
NCT07473284尚未招募不适用

Incidence and Characteristics of Venous Catheter-related Thrombosis Persisting After Catheter Removal in Intensive Care Unit Patients.

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.0 个研究点目标入组 300 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Incidence of catheter related thrombosis persisting in vein after catheter removal.

研究概览

简要总结

The goal of this observational study is to describe characteristics of catheter related thrombosis (CRT) that persists after catheter extraction in condition of intensive care unit. The main questions it aims to answer are:

  1. What is the incidence of CRT that persists after catheter extraction in patients hospitalized in the intensive care unit?
  2. What are the risk factors for this phenomenon?
  3. What is the fate of such a thrombus, including recanalization or the development of complications such as pulmonary embolism or post-thrombotic syndrome?

详细描述

Thrombosis associated with an indwelling central venous catheter (CRT) is a significant phenomenon associated with intensive care. Its incidence can reach up to 41% in intensive care units despite adequate thromboprophylaxis. It manifests itself as the formation of a fibrin coating, thrombotic occlusion of the catheter, mural thrombosis, or complete venous thrombosis. CRT is a frequent reason for catheter removal. However, in these situations, it is not possible to reliably predict the fate of the thrombosis - whether embolization of the thrombus occurs, its removal together with the extracted catheter, or its persistence in the venous bed. Based on our previous clinical observations and studies, it can be stated that in some patients the thrombus is fixed not only to the catheter itself, but also to the venous wall at the site of catheter insertion. After its extraction, the thrombus may persist in the lumen of the vein at the site of the original puncture. The issue of CRT is almost unexplored in the field of intensive care. There are no reliable data on the true incidence of CRT (which is probably underestimated), nor are there standardized recommendations on how to deal with proven thrombosis, what risks it poses to the patient, and whether it is appropriate to perform targeted CRT screening. It is particularly important to identify how often CRT persists after catheter removal, as these patients may be candidates for anticoagulant treatment. Although this fact can significantly influence the therapy strategy both during the ICU stay and after discharge from intensive care, it is a phenomenon that has not been described in detail in the literature. Therefore, we decided to conduct a prospective observational study in which we want to address this specific problem.

Main objectives of the study:

  1. To determine the incidence of venous thrombosis associated with an indwelling central venous catheter that persists in the vein after catheter removal.
  2. To describe the detailed characteristics of this phenomenon in terms of risk factors for thrombosis depending on the type of catheter, insertion site, duration of insertion, and other demographic and clinical parameters. 3. To describe the course of subsequent recanalization of the thrombus and the occurrence of potential complications of thrombosis.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • ICU hospitalization
  • signed informed consent
  • an indwelling central venous catheter planned for extraction

排除标准

  • age under 18 years
  • local pathology precluding ultrasound examination
  • disagreement with participation in the study

研究组 & 干预措施

Observation Cohort

All patient who met inclusion criteria will be enrolled into this observation cohort

干预措施: No Interventions (Other)

结局指标

主要结局

Incidence of catheter related thrombosis persisting in vein after catheter removal.

时间窗: Primary outcome will be known after From date of randomization until last patient is enrolled, up to 30.9.2028

次要结局

  • Description of detailed characteristics associated with persisting CRT after extraction(From date of randomization until last patient is enrolled, up to 30.9.2028)

研究者

发起方
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
申办方类型
Other
责任方
Sponsor

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