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Completed

NCT Number: NCT04194736

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

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.

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Key information

Conditions

Central Venous Catheters Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Ultrasound scan

Other

First ultrasound scan from 1 day to 6 days after the placement of the percutaneous central venous catheter.

Second ultrasound scan from 7 days to 13 days after the placement of the percutaneous central venous catheter if no thrombosis was detected at the first ultrasound scan.

Primary outcomes

  1. Incidence of the occurrence of thrombosis

    Time frame: Until 13 days after the placement of the percutaneous central venous catheter

    Occurrence rate of thrombosis.

Secondary outcomes

  1. Risk factors for thrombosis

    Time frame: Until 13 days after the placement of the percutaneous central venous catheter

    Significant association between diagnosed thrombosis and risk factors, using univariate and multivariate analysis.

  2. Time of onset of thrombosis

    Time frame: Until 13 days after the placement of the percutaneous central venous catheter

    Number of days between the catheter placement and the occurrence of thrombosis.

  3. Therapeutic consequences of a thrombosis diagnosis

    Time frame: Until 13 days after the placement of the percutaneous central venous catheter

    Anticoagulant treatment or/and catheter removal.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: Thromb-US

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2019
Registry last updated
Apr 3, 2026

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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