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N/A N=212 Randomized Treatment

Midlines and Thrombophlebitis

Catheter Infection · Catheter Thrombosis · Catheter Complications

Enrolled (actual)
212
Serious AEs
0.5%
Results posted
Jan 2022
Primary outcome: Primary: Upper Extremity CR-UEVT — 7; 11 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Angiodynamics BioFlo Midline Catheter (Device); Teleflex Arrowg+ard Blue Advanced Midline Catheter (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Corewell Health East
Primary completion
Nov 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Upper Extremity CR-UEVT
7; 11
SECONDARY
Line Related Infection
0; 0

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.

Eligibility Criteria

Inclusion Criteria

  • All inpatients 18 years of age and older
  • Inpatients that require midline catheter placement by the bedside vascular access team

Exclusion Criteria

  • Do not meet inclusion criteria
  • Multiple lumens required
  • Alternative diameter of catheter used
  • If already enrolled once prior
  • Withdraw voluntarily from the study
  • Actively (within 24 hours) taking a therapeutic dose of an anticoagulant (heparin, low molecular weight heparin, enoxaparin, rivaroxaban, apixaban, dabigatran, edoxaban, warfarin, arixtra, factor Xa inhibitors)
  • Receiving a midline catheter for anticoagulant therapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03725293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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