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A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.

Phase 3
17 Years
Not Enrolling
Bacteremia, Neoplasms

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Trial Information

A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.

The most frequent complications of long term TCVC are catheter related blood steam
infections(CRBSI)often caused by microorganisms located in the biofilm formed on the inner
surface of the TCVC after a short time. CRBSI may be lifethreatening, will need long term
intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic
lock therapy. In spite of this CRBSI may often lead to the premature removal of the TCVC.

Several methods to prevent the occurrence of intraluminal microbial colonization have been
investigated with no single method standing out as the optimal one.

There is a need for a simple and safe method of reducing the occurrence of CRBSI in
immunocompromised children receiving chemotherapy for malignant diseases. Various catheter
lock solutions in stead of using heparin have been investigated in experimental models.
Taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity
in vitro. It is claimed to prevent the formation of luminal biofilm in TCVCs in a CVC model
and it has been demonstrated to eradicate infected CVC in a three reports with a total of 18

In a 24 months study of routine use of Taurolidine 1,25%/Sodium-Citrate 4% (TaurolockTM) a
reduction of gram-positive CVC associated infections was demonstrated. The findings were not
statistically significant due to relatively few patients.

There is a need of a larger study with more patients receiving Taurolock for locking the
TCVC between use in order to test for a significant reduction of the occurrence of CRBSI.
Furthermore there is a need for an in vivo demonstration of the reduction of biofilm
formation in TCVCs locked with taurolock compared with TCVCs locked with heparin.

Inclusion Criteria:

- Children aged 0-17 years with malignant disease requiring a tunneled central venous

Exclusion Criteria:

- No written consent from child or parents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group

Outcome Time Frame:

November 2010

Safety Issue:


Principal Investigator

Henrik Schrøder, MD,

Investigator Role:

Study Director

Investigator Affiliation:

Aarhus Universityhospital, Skejby


Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:




Start Date:

April 2008

Completion Date:

September 2012

Related Keywords:

  • Bacteremia
  • Neoplasms
  • Catheterization, Central
  • Catheterization, Peripheral
  • Infection
  • Methods
  • Sepsis
  • Microscopy, Electron, Scanning
  • Sonication
  • Taurolidine
  • Catheters, Indwelling
  • Pediatrics
  • Bacteremia
  • Neoplasms