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Midlines and Thrombophlebitis

NCT03725293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2022-01-14

Study results available
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Summary

Peripherally inserted central catheters (PICCs) are central catheters that are placed via peripheral vein under ultrasound guidance and may be used for patients with difficult venous access for long-term central or peripheral infusion therapies as well as central venous pressure monitoring in a critical care setting. Although PICCs provide a great option for some patients, these catheters have known complications including catheter-related bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high cost. Midline catheters represent a potentially attractive alternative to PICCs for peripheral infusions. As midlines have increased in popularity and new midlines have been introduced into the market, it is necessary to better understand complication profiles of various midline catheters, as it is likely that all catheters are not created equal. Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some midline catheters are coated to provide protection against catheter-related venous thrombosis and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters need further validation in human subjects.

Conditions

  • Catheter Infection
  • Catheter Thrombosis
  • Catheter Complications

Interventions

DEVICE

Angiodynamics BioFlo Midline Catheter

Placement of Angiodynamics BioFlo Midline Catheter.

DEVICE

Teleflex Arrowg+ard Blue Advanced Midline Catheter

Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.

Sponsors & Collaborators

  • Teleflex

    collaborator INDUSTRY

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Amit Bahl, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2020-11-26
Completion
2020-11-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725293 on ClinicalTrials.gov