Status
Conditions
Treatments
About
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.
Full 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:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
444 participants in 2 patient groups
Loading...
Central trial contact
Jovan Xu; Linda Wu
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal