Clinical trial NCT05278507: Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's
Official title: A Prospective, Randomized Study Comparing Device Performance Characteristics and Safety of Arrow Peripherally Inserted Central Catheters With Arrowga+rd Blue Advanced Protection to Standard Unprotected PICCs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripherally Inserted Central Catheter
Keywords: PICC
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: 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.

Patients will receive peripherally-inserted central catheters that are indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. Using randomization, patients will be assigned to receive the institution's standard of care uncoated/unprotected PICC or the study device, the Arrow PICC with Arrowga+rd Blue Advanced Protection

Study Device: Arrow PICC With Arrowga+rd Blue Advanced Protection:

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.

Standard of Care: 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.

Study Design: Prospective, randomized, multicenter study

Number of Subjects: 444 subjects will be enrolled in the study and randomized to receive one of the two PICC devices.

Duration of Subject Study Participation:

Maximum of 92 days, which includes a maximum dwell time of 90 days and follow up 1 to 2 days - 9 days post PICC removal. A subject may remain in the study, with the CVC in place, beyond the expected maximum participant duration (90 days dwell, 1 - 2 day posts removal follow up) if the following conditions are met:

* On day 90 dwell, the subject requires continued PICC access, the assigned PICC remains functional, and it is in the best interest of the subject to continue access via the inserted device.
* It is in the best interest of the subject for the PICC to remain in place, due to health concerns precluding device removal.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: First attempt PICC insertion success
timeFrame: During placement
measure: 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.
timeFrame: During placement
measure: 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
timeFrame: up to 92 days
measure: Incidence of catheter related bloodstream infection assessed by laboratory confirmed bloodstream infection
timeFrame: up to 92 days
Secondary outcomes:
measure: Incidence of complete loss of catheter function versus the total number of effective catheters placed
timeFrame: up to 92 days
measure: Incidence of catheter-associated external wall thrombosis versus the total number of effective catheters placed
timeFrame: up to 92 days
measure: Device performance evaluation
timeFrame: During placement
measure: Evaluation of other safety parameters such as Adverse Events and Device Defects during testing
timeFrame: up to 92 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Doncheng District
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hospital
state: Fengtai District
city: Beijing
country: China
facility: Peking University Third Hospital
state: Haidian District
city: Beijing
country: China
facility: The First Medical Center of Chinese PLA General Hospital
state: Haidian District
city: Beijing
country: China
facility: Peking University People's Hospital
state: Xicheng District
Study officials:
affiliation: Peking University People's Hospital
name: Xiao H Zhang
role: STUDY_CHAIR
References: