Risk Factors for Thrombosis in Children With Central Venous Lines
Analysis of Laboratory Markers to Predict Risk of Catheter Related Thrombosis
1 other identifier
observational
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 22, 2024
October 1, 2019
3.8 years
October 3, 2019
November 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
within one year of enrollment
Study Arms (2)
Central venous lines
Patients having a central venous catheter placed at Banner University Medical Center, University of Arizona
Cardiac catheterization
Patients undergoing a cardiac catheterization procedure done at Banner University Medical Center, University of Arizona
Interventions
We will collect blood samples/biomarkers at the time of enrollment.
Eligibility Criteria
Pediatric patients having central venous line placement
You may qualify if:
- Patients over 5 kg and less than 18 years of age.
- Patients having a central venous catheter or cardiac catheterization performed
You may not qualify if:
- prior history of thrombosis
- patients with hemophilia A or B
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona
Tucson, Arizona, 85724, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 7, 2019
Study Start
March 1, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
November 22, 2024
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share