Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit (Thromb-US)
Primary Purpose
Central Venous Catheters
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Central Venous Catheters focused on measuring Percutaneous central venous catheter, Thrombosis, Children, Ultrasound scan
Eligibility Criteria
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.
Sites / Locations
- Hôpital Necker-Enfants MaladesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children
Arm Description
Minor patients hospitalized in pediatric intensive care unit having a percutaneous central venous catheter.
Outcomes
Primary Outcome Measures
Incidence of the occurrence of thrombosis
Occurrence rate of thrombosis.
Secondary Outcome Measures
Risk factors for thrombosis
Significant association between diagnosed thrombosis and risk factors, using univariate and multivariate analysis.
Time of onset of thrombosis
Number of days between the catheter placement and the occurrence of thrombosis.
Therapeutic consequences of a thrombosis diagnosis
Anticoagulant treatment or/and catheter removal.
Full Information
NCT ID
NCT04194736
First Posted
December 9, 2019
Last Updated
November 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04194736
Brief Title
Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit
Acronym
Thromb-US
Official Title
Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Venous Catheters
Keywords
Percutaneous central venous catheter, Thrombosis, Children, Ultrasound scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children
Arm Type
Experimental
Arm Description
Minor patients hospitalized in pediatric intensive care unit having a percutaneous central venous catheter.
Intervention Type
Other
Intervention Name(s)
Ultrasound scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of the occurrence of thrombosis
Description
Occurrence rate of thrombosis.
Time Frame
Until 13 days after the placement of the percutaneous central venous catheter
Secondary Outcome Measure Information:
Title
Risk factors for thrombosis
Description
Significant association between diagnosed thrombosis and risk factors, using univariate and multivariate analysis.
Time Frame
Until 13 days after the placement of the percutaneous central venous catheter
Title
Time of onset of thrombosis
Description
Number of days between the catheter placement and the occurrence of thrombosis.
Time Frame
Until 13 days after the placement of the percutaneous central venous catheter
Title
Therapeutic consequences of a thrombosis diagnosis
Description
Anticoagulant treatment or/and catheter removal.
Time Frame
Until 13 days after the placement of the percutaneous central venous catheter
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agathe Béranger, MD, PhD
Phone
+33 1 44 49 42 18
Email
agathe.beranger@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Morel
Phone
+33 1 71 19 63 46
Email
helene.morel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agathe Béranger, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agathe Béranger, MD, PhD
Phone
+33 1 44 49 42 18
Email
agathe.beranger@aphp.fr
First Name & Middle Initial & Last Name & Degree
Judith Chareyre, MD
First Name & Middle Initial & Last Name & Degree
David Grevent, MD
First Name & Middle Initial & Last Name & Degree
Ségolène Bernheim, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Occurrence of Early Thrombosis on Central Venous Catheter by Ultrasound in Pediatric Intensive Care Unit
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