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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04194736
Acronym
Thromb-US
Enrollment
81
Registered
2019-12-11
Start date
2021-06-10
Completion date
2023-06-28
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheters

Keywords

Percutaneous central venous catheter, Thrombosis, Children, Ultrasound scan

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.

Interventions

OTHERUltrasound 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of the occurrence of thrombosisUntil 13 days after the placement of the percutaneous central venous catheterOccurrence rate of thrombosis.

Secondary

MeasureTime frameDescription
Risk factors for thrombosisUntil 13 days after the placement of the percutaneous central venous catheterSignificant association between diagnosed thrombosis and risk factors, using univariate and multivariate analysis.
Time of onset of thrombosisUntil 13 days after the placement of the percutaneous central venous catheterNumber of days between the catheter placement and the occurrence of thrombosis.
Therapeutic consequences of a thrombosis diagnosisUntil 13 days after the placement of the percutaneous central venous catheterAnticoagulant treatment or/and catheter removal.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAgathe Béranger, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026