Title: A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters. Protocol # 011-ACVC05
Principal Investigator: Stephen Heard, M.D.
Purpose of Research
The purpose of this study is to find out whether the experimental Angiotech Central Venous Catheter (CVC) is safe and effective in preventing bacterial infections where the catheter is inserted, and in the bloodstream, compared with the ARROWgard Blue® Central Venous Catheter (CVC).
The Angiotech device is a central venous catheter (CVC) with a coating that contains the active ingredient 5-FU (fluorouracil). The Angiotech CVC uses a 1 milligram (mg) dose of 5-FU, which is released over 28 days.
The ARROWgard Blue® CVC is a standard type of CVC currently in use. Within the material of its tube are two anti-infective compounds (the active ingredients): chlorhexidine and silver sulfadiazine.
- written informed consent (or have consent provided by a legally authorized representative)
- age between 18 and 80 years of age (inclusive)
- initially hospitalized in an intensive care setting
- require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days
- be willing to comply with all aspects of the treatment and evaluation schedule
- allow representatives of the sponsor, designated contract research organization (CRO), institutional review board (IRB), Ethics Committee (EC), and national and international health agencies to review his/her relevant medical records; and
- if female and of child-bearing potential, provide evidence of a negative pregnancy test
- participated in another research study within the last 30 days
- a life expectancy of less than one month
- a history of anaphylactic reactions, including reactions to contrast dyes; and
- a history of allergy to 5-fluorouracil (5‑FU) or chlorhexidine