Long Peripheral Catheter for Vascular Access Device Complications

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Wisconsin, Milwaukee, WI
Vascular Access Device Complications
Long Peripheral Catheter - Device
Eligibility
< 18
All Sexes
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Study Summary

Peripherally Inserted Central Catheters (PICCs) are frequently used in hospitalized children who require prolonged vascular access; however, concerns regarding their inappropriate use and contribution to serious complications such as central line associated blood stream infection (CLABSI) and venous thromboembolism (VTE) have triggered exploration of safer alternatives. Long Peripheral Catheters (LPCs) have been recently adopted by some institutions due to fewer complications as compared to PICCs. The investigators hypothesize that LPCs could be safer alternatives to PICCs for medium-term vascular access (5-14 days) in the appropriate cohort of hospitalized pediatric patients. The primary objective of the proposed clinical effectiveness pilot trial is to test the feasibility of a full-scale effectiveness trial comparing PICCs to LPCs in hospitalized pediatric patients. The investigators aim to identify a population in which LPCs are safe and effective alternatives to PICCs for medium-term, non-central vascular access; data that will inform the design of a full-scale effectiveness study. The investigators plan to engage patients and families as advisors in vascular access device selection by understanding their experience with vascular access device placement and maintenance. Over time, use of LPCs should result in decreased inappropriate PICC utilization with a concomitant decrease in serious complications such as CLABSI and VTE.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Vascular Access Device Complications

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Through the study completion, an average of 1 year

1 day
Average time-to-placement of VAD
Percent participants with prolonged NPO (nothing by mouth) time
Day 1
Percent participants that received sedation for VAD placement
Day 14
Average dwell-time
Percent VADs successfully used for blood draws
Percent completion of therapy with initial VAD
Percent participants requiring additional VADs to complete therapy
The composite rate of complications
Year 1
Number of feasibility measures accomplished

Trial Safety

Safety Progress

1 of 3

Other trials for Vascular Access Device Complications

Trial Design

2 Treatment Groups

Peripherally Inserted Central Catheter
1 of 2
Long Peripheral Catheter
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Long Peripheral Catheter · No Placebo Group · N/A

Long Peripheral Catheter
Device
Experimental Group · 1 Intervention: Long Peripheral Catheter · Intervention Types: Device
Peripherally Inserted Central Catheter
Device
ActiveComparator Group · 1 Intervention: Peripherally Inserted Central Catheter · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through the study completion, an average of 1 year

Trial Background

Prof. Alina Burek, Assistant Professor
Principal Investigator
Medical College of Wisconsin
Closest Location: Children's Wisconsin · Milwaukee, WI
Photo of Milwaukee  1Photo of Milwaukee  2Photo of Milwaukee  3
2019First Recorded Clinical Trial
1 TrialsResearching Vascular Access Device Complications
2 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References