Incidence and Risk Factors of Central Line Catheter Related Thrombosis

March 3, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital

Study About the Incidence and Risk Factors of the Central Line Catheter Related Right Internal Jugular Vein Thrombosis in Pediatric Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric patients

Description

Inclusion Criteria:

  • pediatric patients who were scheduled to catheterize central venous catheter

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thrombus formation using doppler ultrasound examination of internal jugular vein
Time Frame: after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days)
after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2018

Primary Completion (ACTUAL)

April 8, 2020

Study Completion (ACTUAL)

April 8, 2020

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (ACTUAL)

March 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1801-152-922

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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