Risk Factors for Thrombosis in Children With Central Venous Lines

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Venous Thromboembolism
• Intervention / Treatment: Diagnostic test: Labs drawn

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients having central venous line placement

Description

Inclusion Criteria:

• Patients over 5 kg and less than 18 years of age.
• Patients having a central venous catheter or cardiac catheterization performed

Exclusion Criteria:

• prior history of thrombosis
• patients with hemophilia A or B

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Central venous lines; Patients having a central venous catheter placed at Banner University Medical Center, University of Arizona	Diagnostic test: Labs drawn; We will collect blood samples/biomarkers at the time of enrollment.
Cardiac catheterization; Patients undergoing a cardiac catheterization procedure done at Banner University Medical Center, University of Arizona	Diagnostic test: Labs drawn; We will collect blood samples/biomarkers at the time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 1701146088R002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No