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Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?

W

Western Galilee Hospital-Nahariya

Status and phase

Completed
Phase 3

Conditions

Hemodialysis
End Stage Renal Disease

Treatments

Other: Catheter Lock Solution : Heparin
Other: Catheter Lock Solution Taurolidine and Citrate
Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin

Study type

Interventional

Funder types

Other

Identifiers

NCT00749619
TAURO 070908

Details and patient eligibility

About

Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.

Full description

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.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Hemodialysis patients with new TCC
  • Informed Consent

Trial design

0 participants in 3 patient groups

A
Experimental group
Treatment:
Other: Catheter Lock Solution Taurolidine and Citrate
B
Experimental group
Treatment:
Other: Catheter Lock Solution :Taurolidine and Citrate and Heparin
C
No Intervention group
Treatment:
Other: Catheter Lock Solution : Heparin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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