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MethLock vs. heparin as dialysis catheter lock

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
76175
Program Year/Program:
2005 / SBIR
Agency Tracking Number:
DK071369
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
ASH ACCESS TECHNOLOGY, INC.
3601 SAGAMORE PARKWAY N STE B LAFAYETTE, IN 47904 5033
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2005
Title: MethLock vs. heparin as dialysis catheter lock
Agency: HHS
Contract: 1R44DK071369-01
Award Amount: $100,000.00
 

Abstract:

DESCRIPTION (provided by applicant): Currently about 25% of patients on hemodialysis therapy for End Stage Renal Disease (ESRD) receives dialysis through tunneled central venous catheters for dialysis (CVCD). The standard anticoagulant lock for these catheters is heparin, which has no antibacterial properties. The greatest risk for ESRD patients using CVCDs access is catheter related bloodstream infection (CRBSI), with frequent progression to sepsis. MethLock(tm) is a catheter lock comprised of methylene blue (an antibacterial substance) and sodium citrate (7%, an anticoagulant). In vitro studies of MethLock have shown that it is bactericidal for all bacteria, even in the presence of diluted blood or culture medium. This Phase I and Phase II grant application will support a multi-center randomized trial of the safety and effectiveness of MethLock versus heparin as a catheter lock in tunneled CVCD. The protocol has been approved by the FDA and an IDE granted for MethLock for the trial. The primary endpoints are CRBSI (concordant bacterial culture drawn from peripheral blood and the catheter lumen) and removal of the catheter for patency failure (after demonstration of at least 25% decrease in flow rate during dialysis versus a baseline treatment). Each patient will be followed for up to 6 months, and the size of the study (400 patients) will provide enough data to demonstrate whether MethLock decreases the incidence CRBSI versus heparin while maintaining patency of catheters equal to heparin. The endpoints of the study are objective and easily definable but have not been validated in a full-scale clinical trial of CVCD or catheter lock. In Phase I we will implement the protocol at one dialysis center (a "pilot" center) to determine the practicality of the trial, analyzing: the ease of patient enrollment, speed of identification of adverse events, and the general correlation between our defined endpoints and clinical interventions by staff on the CVCDs. After Phase I we will determine whether the protocol needs to be modified and if so will request protocol modifications from the FDA. In Phase II we will implement the protocol in a number of dialysis centers and complete the study as originally proposed or as modified after Phase I.

Principal Investigator:

Stephen R. Ash
7657424813
sash@hemocleanse.com

Business Contact:


7657424813
Small Business Information at Submission:

Ash Access Technology, Inc.
3601 Sagamore Parkway N Ste B Lafayette, IN 47904

EIN/Tax ID: 351571341
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No