Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's

NCT05278507 | Unknown FDA Device

• 1 other identifier: 2018-10
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 5

Brief Summary

This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording treatment response when diagnosed by sluggish fluid flow, inability to aspirate blood and or difficulty/inability to infuse via a lumen or lumens of the catheter. The incidence of catheter-related bloodstream infection will also be tracked during the study.

Conditions

Peripherally Inserted Central Catheter

Keywords

PICC

Outcome Measures

Primary Outcomes (4)

• First attempt PICC insertion success

  rate of first attempt insertion success = number of patients with first attempt insertion /total number of patients \*100% • First attempt insertion success and number of failed attempts will be documented

  During placement

• PICC Placement Success - Confirmation of tip placement in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented.

  Once the PICC placement is complete, confirmation of catheter tip location in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented. Any adjustments to catheter length post-insertion must be performed using sterile technique and maximal barrier precautions. The number of adjustments to the inserted PICC needed to achieve proper tip location will be recorded.

  During placement

• Confirmation of tip patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP

  Once the PICC placement is complete, the inserter will confirm patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP. For inpatients, each lumen will be assessed for patency at least every 12 hours and/or before administration of infusion therapies. Patency assessments will be documented. * Patency checks resulting in brisk blood return and ability to flush easily will be considered patent. * Patency checks resulting in inability to aspirate blood with ability to flush easily will be documented as a withdrawal occlusion. * Patency checks resulting in sluggish flow and/or ability to flush will be documented as a partial occlusion. * Patency checks resulting in inability to aspirate blood and inability to flush will be documented as a complete occlusion.

  up to 92 days

• Incidence of catheter related bloodstream infection assessed by laboratory confirmed bloodstream infection

  Subjects will be assessed for laboratory confirmed bloodstream infection (LCBI) as described below through one day post PICC removal LCBI 1 Patient of any age has a recognized pathogen, which is an organism not included on the NHSN common commensal list, identified from one or more blood specimens obtained by a culture or non-culture based microbiologic testing method (excluding organisms identified by testing on sera) AND Organism(s) identified in blood is not related to an infection at another site LCBI 2 Patient of any age has at least one of the following signs or symptoms: fever (\>38.0oC), chills, or hypotension AND Organism(s) identified in blood is not related to an infection at another site AND The same NHSN common commensal is identified by a culture or non-culture based microbiologic testing method, from two or more blood specimens collected on separate occasions.

  up to 92 days

Secondary Outcomes (4)

• Incidence of complete loss of catheter function versus the total number of effective catheters placed

  up to 92 days

• Incidence of catheter-associated external wall thrombosis versus the total number of effective catheters placed

  up to 92 days

• Device performance evaluation

  During placement

• Evaluation of other safety parameters such as Adverse Events and Device Defects during testing

  up to 92 days

Study Arms (2)

Arrow PICC With Arrowga+rd Blue Advanced Protection

EXPERIMENTAL

The Arrow PICC with Arrowga+rd Blue Advanced protection (Teleflex Medical Incorporated, Morrisville, NC, USA; hereafter referred to as "AGBA") is an FDA-cleared pressure injectable device that offers both antimicrobial and anti-thrombogenic protection for at least 30 days. The application of Arrowga+rd Blue Advanced protection uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body. The device is cleared for marketing in the United States of America by the Food and Drug Administration, and has obtained the CE mark for marketing in the European Union. The French size and length selected for use will be documented.

Device: Arrowga+rd Blue Advance Protection PICC Placement

Standard of Care PICC

SHAM COMPARATOR

The standard, unprotected PICC currently in use at the institution will be used in this study (here after referred to as Standard). The details of the PICC selected will be recorded including brand, French size, and length.

Device: Sham Comparator PICC placement

Interventions

Arrowga+rd Blue Advance Protection PICC Placement DEVICE

The PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU.

Arrow PICC With Arrowga+rd Blue Advanced Protection

Sham Comparator PICC placement DEVICE

The sham comparator PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU.

Standard of Care PICC

Eligibility Criteria

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

You may qualify if:

• Patients age ≥ 18 years requiring a PICC
• Patient will remain an inpatient for the entire dwell time
• Ability to comply with study requirements of duplex ultrasound procedures prior to and at the time of PICC removal
• Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study

You may not qualify if:

• Current diagnosis of venous thrombosis within the venous tract of the proposed catheter
• Diagnosis of peripheral or central vein stenosis (on proposed insertion side)
• History or diagnosis of veno-occlusive disease
• Diagnosis of superior vena cava syndrome
• Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
• Previous enrollment in this study
• Currently pregnant or breast feeding
• Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis
• Medical, social, and/or psychological problems precluding subject from study participation
• Known allergy or sensitivity to chlorhexidine

Sponsors & Collaborators

• Teleflex: lead

Study Sites (5)

Beijing Hospital

Beijing, Doncheng District, 100730, China

RECRUITING

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Fengtai District, 100039, China

RECRUITING

Peking University Third Hospital

Beijing, Haidian District, 100191, China

RECRUITING

The First Medical Center of Chinese PLA General Hospital

Beijing, Haidian District, 100853, China

RECRUITING

Peking University People's Hospital

Beijing, Xicheng District, 100044, China

RECRUITING

Study Officials

• Xiao H Zhang

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Linda Wu

CONTACT

15010697631; lindi.wu@teleflex.com

Jovan Xu

CONTACT

86106411; Jovan.Xu@teleflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The primary purpose of this study is to prospectively collect outcome data in order to evaluate the performance and safety of the Arrowga+rd Blue Advanced PICC with regard to first attempt insertion success and incidence of complications as compared to use of standard, unprotected PICC devices.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 14, 2022
• Study Start: January 16, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 23, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Permanently after trademark registrations
• Access Criteria: Investigators whose proposed research has received IRB/EC approval

Locations

CN (5)