NCT04194736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 9, 2019

Last Update Submit

January 27, 2026

Conditions

Central Venous Catheters

Keywords

Percutaneous central venous catheterThrombosisChildrenUltrasound scan

Outcome Measures

Primary Outcomes (1)

  • Incidence of the occurrence of thrombosis

    Occurrence rate of thrombosis.

    Until 13 days after the placement of the percutaneous central venous catheter

Secondary Outcomes (3)

  • Risk factors for thrombosis

    Until 13 days after the placement of the percutaneous central venous catheter

  • Time of onset of thrombosis

    Until 13 days after the placement of the percutaneous central venous catheter

  • Therapeutic consequences of a thrombosis diagnosis

    Until 13 days after the placement of the percutaneous central venous catheter

Study Arms (1)

Children

EXPERIMENTAL

Minor patients hospitalized in pediatric intensive care unit having a percutaneous central venous catheter.

Other: Ultrasound scan

Interventions

Ultrasound scanOTHER

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.

Children

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- All children hospitalized in pediatric intensive care unit requiring the placement of a central venous catheter.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Thrombosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Agathe Béranger, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

June 10, 2021

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)