NCT04117217

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 22, 2024

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

October 3, 2019

Last Update Submit

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

Diagnostic Test: Labs drawn

Cardiac catheterization

Patients undergoing a cardiac catheterization procedure done at Banner University Medical Center, University of Arizona

Diagnostic Test: Labs drawn

Interventions

Labs drawnDIAGNOSTIC_TEST

We will collect blood samples/biomarkers at the time of enrollment.

Cardiac catheterizationCentral venous lines

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations