Pediatric Venous ThromboembolismNCT04117217
Risk Factors for Thrombosis in Children With Central Venous Lines
An observational study of Pediatric Venous Thromboembolism, run by University of Arizona at 1 site in United States.
Trial summary
This project addresses the role of lab markers around the time of central line placement in predicting risk of thrombosis in pediatric patients with central venous lines being placed. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Pediatric Venous Thromboembolism
- What is being tested?
- Labs drawn
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 31 Dec 2021
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients having central venous line placement
Who may be able to join
- Patients over 5 kg and less than 18 years of age.
- Patients having a central venous catheter or cardiac catheterization performed
Who cannot join
- prior history of thrombosis
- patients with hemophilia A or B
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Laboratory Markers to Predict Risk of Catheter Related Thrombosis
This project addresses the role of lab markers around the time of central line placement in predicting risk of thrombosis in pediatric patients with central venous lines being placed. The project proposes an innovative way to predict higher risk of thrombosis in the pediatric population to give clinicians a valid tool to guide clinical practice for these patients.
- Conditions
- Pediatric Venous Thromboembolism
- Being tested
- Labs drawn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labs drawnDiagnostic test
We will collect blood samples/biomarkers at the time of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Central venous lines | Patients having a central venous catheter placed at Banner University Medical Center, University of Arizona Receives: Diagnostic Test: Labs drawn | |
| Cardiac catheterization | Patients undergoing a cardiac catheterization procedure done at Banner University Medical Center, University of Arizona Receives: Diagnostic Test: Labs drawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Patients will be enrolled during the time of central line placements and labs would be drawn during line placement. Patients will be followed prospectively for a catheter related t thrombosis event or not. Lab markers and clinical states of patients who develop or do not develop a thrombosis will be analyzed
Measured: within one year of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Mar 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117217
- Sponsor's protocol ID
- 1701146088R002
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Laboratory Markers to Predict Risk of Catheter Related Thrombosis
- ClinicalTrials.gov ID
- NCT04117217
- Acronym / sponsor ID
- 1701146088R002
- Conditions
- Pediatric Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Oct 2019 (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.
This project addresses the role of lab markers around the time of central line placement in predicting risk of thrombosis in pediatric patients with central venous lines being placed. The project proposes an innovative way to predict higher risk of thrombosis in the pediatric population to give clinicians a valid tool to guide clinical practice for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central venous lines | – | Diagnostic Test: Labs drawnPatients having a central venous catheter placed at Banner University Medical Center, University of Arizona |
| Cardiac catheterization | – | Diagnostic Test: Labs drawnPatients undergoing a cardiac catheterization procedure done at Banner University Medical Center, University of Arizona |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients having central venous line placement
Key inclusion criteria (2 listed)
- Patients over 5 kg and less than 18 years of age.
- Patients having a central venous catheter or cardiac catheterization performed
Key exclusion criteria (2 listed)
- prior history of thrombosis
- patients with hemophilia A or B
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 |
|---|---|---|
| Labs drawnWe will collect blood samples/biomarkers at the time of enrollment. | Diagnostic test | Cardiac catheterization, Central venous lines |
Primary outcome
Thrombosis
Time frame: within one year of enrollment
Patients will be enrolled during the time of central line placements and labs would be drawn during line placement. Patients will be followed prospectively for a catheter related t thrombosis event or not. Lab markers and clinical states of patients who develop or do not develop a thrombosis will be analyzed
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
Venous Thromboembolism (VTE)
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 Pediatric Venous Thromboembolism, run by University of Arizona at 1 site in United States.
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 2 inclusion and 2 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 22 Nov 2024. 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 United States. 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?
Thrombosis (time frame: within one year of enrollment). 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 22 Nov 2024.