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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04194736
Other study ID # APHP191078
Secondary ID 2019-A02893-54
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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