Ignite Creation Date:
2025-12-17 @ 9:39 PM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT00749619
Status:
None
Last Update Posted:
2008-09-09 00:00:00
First Post:
2008-09-07 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?
Sponsor:
None
Organization:
Study Overview
Official Title:
None
Status:
None
Status Verified Date:
2008-09
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:
Bacteremia and thrombosis are the major complications of TCC used for hemodialysis.Instilation of CLS containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent Catheter related bacteremia (CRB).In previous study in our department, Taurolock-TM decreased the rate of CRB but increased the incidence of catheter malfunction.
The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine \&citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention.
Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes.
The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.
The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine \&citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention.
Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes.
The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: