Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-04 @ 7:49 PM
Study NCT ID:
NCT00157651
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Study Overview
Official Title:
A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.
Detailed Description:
Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: