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临床试验/NCT04194736
NCT04194736已完成不适用

Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Incidence of the occurrence of thrombosis

研究概览

简要总结

The objective of this study is to prospectively describe the incidence of early venous thrombosis secondary to the placement of a percutaneous central venous catheter, in a pediatric intensive care unit, by systematic ultrasound screening.

详细描述

In pediatric resuscitation, the use of a percutaneous central venous catheter is essential. It allows to administer strong osmolarity intravenous drugs or prolonged duration treatment and to carry out blood samples.

In the course of the placement of a central venous catheter, there is a risk of occurrence of early thrombosis between 20 and 45%, appearing mainly in the 4 first days. The occurrence is explained by the Virchow triad: endothelial lesion (linked to the central venous catheter), venous stasis, hypercoagulability. Ultrasonography is an imaging test that can be performed at the bedside, allowing the non-invasive collection of diagnostic elements of thrombosis (visible thrombus, non-compressibility of the vein, abolition of venous flow). Performing ultrasound for thrombosis screening is essential because of a very low clinical expression of thrombosis, while the consequences are potentially severe, including infection, embolism, venous insufficiency and loss of venous access for children who will need several central venous catheters during their lifetime.

Despite the knowledge of certain risk factors (i.e. assisted ventilation, history of cancer, transfusions,...), there is actually no consensus for the systematic screening of venous thromboses on central venous catheters. Systematic thromboprophylaxis is not recommended for central venous catheters (grade 1B). Concerning the curative treatment of central venous catheter thrombosis, unfractionated heparin or low molecular weight heparin (grade 1B) is recommended. If the central venous catheter is no longer needed for the care, it can be removed after 3 to 5 days of anticoagulants (grade 2C). It can also be kept under cover of anticoagulant treatment if its use is essential (grade 2C).

The objective of this study is to prospectively describe the incidence of early venous thrombosis secondary to the placement of a percutaneous central venous catheter, in a pediatric intensive care unit, by the systematic ultrasound screening.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • - All children hospitalized in pediatric intensive care unit requiring the placement of a central venous catheter.

排除标准

  • Impossibility of delivering an information in order to obtain a non-opposition.
  • Absence of acoustic window (dressings).
  • Removal of the catheter before performing the ultrasound.

研究组 & 干预措施

Children

Experimental

Minor patients hospitalized in pediatric intensive care unit having a percutaneous central venous catheter.

干预措施: Ultrasound scan (Other)

结局指标

主要结局

Incidence of the occurrence of thrombosis

时间窗: Until 13 days after the placement of the percutaneous central venous catheter

Occurrence rate of thrombosis.

次要结局

  • Therapeutic consequences of a thrombosis diagnosis(Until 13 days after the placement of the percutaneous central venous catheter)
  • Risk factors for thrombosis(Until 13 days after the placement of the percutaneous central venous catheter)
  • Time of onset of thrombosis(Until 13 days after the placement of the percutaneous central venous catheter)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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