NCT03450785

Brief Summary

Central venous catheters are frequently used for monitoring haemodynamic status and rapidly delivering fluid therapy during the peri- and postoperative periods. Indwelling central venous catheters are typically used 7-14 days postoperatively for additional monitoring and treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to life-threatening pulmonary embolism and death. Early detection helps to avoid such complications. This prospective observational study investigated the risk factors associated with catheter-related right internal jugular vein thrombosis in pediatric patients. The study enrolled 80 pediatric patients who were scheduled to receive central venous catheter. To detect thrombus formation, Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

February 22, 2018

Last Update Submit

March 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • thrombus formation using doppler ultrasound examination of internal jugular vein

    after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days)

Interventions

Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients

You may qualify if:

  • pediatric patients who were scheduled to catheterize central venous catheter

You may not qualify if:

  • patients who had skin infections on the right side of the neck, making them unsuitable for placement of the catheter via the right side of the neck
  • patients who had blood coagulation lesions or bleeding tendencies
  • patients with thrombocytopenia
  • patients with a history of right internal jugular vein thrombosis
  • patients who presented right internal jugular vein thrombosis or stenosis on preoperative Doppler ultrasound examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 1, 2018

Study Start

March 7, 2018

Primary Completion

April 8, 2020

Study Completion

April 8, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations