Midlines and Thrombophlebitis

NCT03725293 | Completed Results FDA Device

• 1 other identifier: 2018-379
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

thrombosis; superficial venous thrombosis; deep venous thrombosis; line related infection; catheter survival

Outcome Measures

Primary Outcomes (1)

• Upper Extremity CR-UEVT

  Number of participants with proven sonographic diagnosis of DVT and/or SVT

  30 days post line insertion

Secondary Outcomes (1)

• Line Related Infection

  30 days post line insertion

Study Arms (2)

Angiodynamics BioFlo Midline Catheter

ACTIVE COMPARATOR

Placement of clinically indicated Angiodynamics BioFlo midline catheter.

Device: Angiodynamics BioFlo Midline Catheter

Teleflex Arrowg+ard Blue Advanced Midline Catheter

ACTIVE COMPARATOR

Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter

Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter

Interventions

Angiodynamics BioFlo Midline Catheter DEVICE

Placement of Angiodynamics BioFlo Midline Catheter.

Angiodynamics BioFlo Midline Catheter

Teleflex Arrowg+ard Blue Advanced Midline Catheter DEVICE

Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.

Teleflex Arrowg+ard Blue Advanced Midline Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead
• Teleflex: collaborator

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Related Publications (2)

• Bahl A, Johnson S, Mielke N, Chen NW. Risk Factors for Coated Midline Catheter-Related Thrombosis: A Secondary Analysis of Existing Trial Data. J Infus Nurs. 2023 Sep-Oct 01;46(5):259-265. doi: 10.1097/NAN.0000000000000518.

  PMID: 37611283 DERIVED

• 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.

  PMID: 34613402 DERIVED

MeSH Terms

Conditions

Thrombosis; Venous Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Amit Bahl, MD
• Organization: Beaumont Hospitals

ahmit.bahl@beaumont.edu

(248) 898-9111

Study Officials

• Amit Bahl, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Emergency Ultrasound

Model Details: Prospective single-site, parallel, two-arm, randomized investigation

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 31, 2018
• Study Start: January 14, 2019
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)