Central Line ComplicationNCT03450785
Incidence and Risk Factors of Central Line Catheter Related Thrombosis
An observational study of Central Line Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Central Line Complication
- What is being tested?
- ultrasound examination
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2018to 8 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients
Who may be able to join
- pediatric patients who were scheduled to catheterize central venous catheter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Central Line Complication
- Being tested
- ultrasound examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombus formation using doppler ultrasound examination of internal jugular vein
Measured: after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start7 Mar 2018
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450785
- Sponsor's protocol ID
- 1801-152-922
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2018
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About the Incidence and Risk Factors of the Central Line Catheter Related Right Internal Jugular Vein Thrombosis in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03450785
- Acronym / sponsor ID
- 1801-152-922
- Conditions
- Central Line Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients
Key inclusion criteria (1 listed)
- pediatric patients who were scheduled to catheterize central venous catheter
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound examinationDoppler 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. | Other | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Line Complication, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.