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

Central Venous Catheters Clinical Trial

— Thromb-US  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194736
• Other study ID #: APHP191078
• Secondary ID: 2019-A02893-54
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheters
• Thrombosis

Intervention

Other:
• Ultrasound scan
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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the occurrence of thrombosis	Occurrence rate of thrombosis.	Until 13 days after the placement of the percutaneous central venous catheter
Secondary	Risk factors for thrombosis	Significant association between diagnosed thrombosis and risk factors, using univariate and multivariate analysis.	Until 13 days after the placement of the percutaneous central venous catheter
Secondary	Time of onset of thrombosis	Number of days between the catheter placement and the occurrence of thrombosis.	Until 13 days after the placement of the percutaneous central venous catheter
Secondary	Therapeutic consequences of a thrombosis diagnosis	Anticoagulant treatment or/and catheter removal.	Until 13 days after the placement of the percutaneous central venous catheter