Midlines and Thrombophlebitis

Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis

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.

Study Overview

• Status: Completed
• Conditions: Catheter Infection; Catheter Complications; Catheter Thrombosis
• Intervention / Treatment: Device: Angiodynamics BioFlo Midline Catheter; Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter

Detailed Description

Study Design

The investigators propose a prospective single-site, parallel, two-arm, randomized investigation to assess catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.

Research staff of Beaumont Health Institute will allocate two midline catheters to eligible participants according to a pre-generated randomized list at a 1:1 ratio in block randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline catheters. Participant enrollment will take place from November 2018 until recruitment of 250 participants, 125 in each group, is complete. Demographic and health-related information will be obtained from electronic medical records during enrolled period at William Beaumont Hospital.

Practitioner Participation/Training

Advanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus are eligible to place catheters for this study. All investigators are credentialed in placing PICCs and midlines by institutional policy and have greater than one year of experience in these procedures.

Initial Assessment

Post-cannulation and post securement, functionality is confirmed with blood sampling (10 cc) and flush without resistance.

The research team also will document practitioner details, the vascular access device (VAD) used, the time of VAD placement, number of attempts, need for a rescue inserter, the vein that was cannulated, depth and diameter of the vein, and the indication for VAD placement. An attempt is defined as each time the needle punctures the skin. Data will be collected from the electronic medical record and includes: age, gender, body mass index (BMI), vital signs, relevant past medical history. Indication for catheter placement will also be recorded.

Follow-up Assessment

Investigators will perform a follow-up assessment on all catheters within 24 hours of insertion and then daily for the life of the VAD. At each follow-up interval, the researcher will document the time of evaluation and assessment of functionality as well as review the patient chart for signs and symptoms of catheter-related bloodstream infection. If the catheter was identified to have failed during follow-up assessment the date and time of failure and the reason for failure will be documented. For all failed catheters, re-insertion attempt data will be tracked through the medical record.

Superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates will be calculated based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic cases. Radiology interpretations will be reviewed for findings consistent with CR-UEVT.

Infection rate will be tracked using confirmed catheter-related blood stream infection data from the surveillance team within the epidemiology department. The team utilizes the CDC definition of laboratory-confirmed blood-stream infection (LCBSI).

The medication administration record will be queried for all medications given through each catheter.

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital - Royal Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiodynamics BioFlo Midline Catheter; Placement of clinically indicated Angiodynamics BioFlo midline catheter.	Device: Angiodynamics BioFlo Midline Catheter; Placement of Angiodynamics BioFlo Midline Catheter.
Active Comparator: Teleflex Arrowg+ard Blue Advanced Midline Catheter; Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter	Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter; Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity CR-UEVT	Number of participants with proven sonographic diagnosis of DVT and/or SVT	30 days post line insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Line Related Infection	Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines	30 days post line insertion

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Collaborators: Teleflex

Publications and helpful links

General Publications

• Bahl A, Diloreto E, Jankowski D, Hijazi M, Chen NW. Comparison of 2 Midline Catheter Devices With Differing Antithrombogenic Mechanisms for Catheter-Related Thrombosis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127836. doi: 10.1001/jamanetworkopen.2021.27836.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 26, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: thrombosis; deep venous thrombosis; superficial venous thrombosis; line related infection; catheter survival
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Peripheral Vascular Diseases; Phlebitis; Thrombosis; Thrombophlebitis
• Other Study ID Numbers: 2018-379

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: Yes
• product manufactured in and exported from the U.S.: Yes