Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit (Thromb-US)

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheters
• Intervention / Treatment: Other: Ultrasound scan

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agathe Béranger, MD, PhD; Phone Number: +33 1 44 49 42 18; Email: agathe.beranger@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children; Minor patients hospitalized in pediatric intensive care unit having a percutaneous central venous catheter.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the occurrence of thrombosis	Occurrence rate of thrombosis.	Until 13 days after the placement of the percutaneous central venous catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Therapeutic consequences of a thrombosis diagnosis	Anticoagulant treatment or/and catheter removal.	Until 13 days after the placement of the percutaneous central venous catheter

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Agathe Béranger, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Children; Thrombosis; Percutaneous central venous catheter; Ultrasound scan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: APHP191078; 2019-A02893-54 (Other Identifier: IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No