Dialysis Catheter Infections Clinical Trial
Official title:
Multi-Center, Prospective, Randomized, Open-Label, Sponsor-Blinded, Active-Control (Heparin) Clinical Investigation to Evaluate the Safety and Effectiveness of B-Lock™ as an Antimicrobial Catheter Lock Solution in Dialysis Patients With a Central Venous Catheter
Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain
catheter patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in
dialysis patients using a central venous catheter (CVC) for vascular access.
The study is a prospective, randomized, site unblinded/sponsor blinded, clinical study of a
minimum of 300 dialysis patients using a central venous catheter (CVC) for vascular access.
Patients will be randomized 1:1 to receive either the investigational medical device (B-Lock
or IMD) or active control heparin (5000 U/mL) (ACH) and observed for a minimum of 45 days or
a maximum of 273 (expected average 160 days). IMD or ACH will be instilled into the catheter
lumens (dual lumen catheters) at the end of each dialysis session and removed prior to the
initiation of the next dialysis session.
The primary objectives of this study are:
- To demonstrate the safety of B-Lock in dialysis patients
- To demonstrate the non-inferiority or, if proven to be non-inferior, superiority of
B-Lock relative to ACH with respect to maintaining catheter patency as defined by the
use of recombinant tissue plasminogen activator for maintaining adequate blood flow
through the dialysis catheter
- To demonstrate the superiority of B-Lock relative to ACH with respect to the incidence
of CLABSI
n/a