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

Not Applicable

Completed

• Conditions: Central Venous Catheters
• Interventions: Other: Ultrasound scan

• Registration Number: NCT04194736
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2021-06-10
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children	Ultrasound scan	Minor patients hospitalized in pediatric intensive care unit having a percutaneous central venous catheter.

Primary Outcome Measures

Name	Time	Method
Incidence of the occurrence of thrombosis	Until 13 days after the placement of the percutaneous central venous catheter	Occurrence rate of thrombosis.

Secondary Outcome Measures

Name	Time	Method
Therapeutic consequences of a thrombosis diagnosis	Until 13 days after the placement of the percutaneous central venous catheter	Anticoagulant treatment or/and catheter removal.
Risk factors for thrombosis	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.
Time of onset of thrombosis	Until 13 days after the placement of the percutaneous central venous catheter	Number of days between the catheter placement and the occurrence of thrombosis.

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France