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Taurolidine

Tunneled central venous catheters locked with Taurolock

Tunneled central venous catheter locked with heparin

When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.

Taurolock

When not in use the childrens tunneled central venous catheters are locked with heparin

Henrik Schrøder, MD, Dr.med.

Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.

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 patients.

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.

Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

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

Danish Child Cancer Foundation

TauroPharm

Aarhus University Hospital

MD, PhD

Blood and Lymph Conditions

Hematologic Diseases

In the intervention group the use of heparin as locking solution in the catheter lumen (or lumina) when the catheter is not longer in use is omitted. Catheters are locked under positive pressure with normal saline in stead injecting an extra volume of heparinised saline (100IU/ml).

Ten milliliters of normal saline will be injected at the end of the intravenous therapy. Injection is performed with the start/stop method and with the positive pressure technique (clamping the catheter while injecting the last milliliters of normal saline)

normal saline

Marguerite Stas, MD, PhD

Long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. For years these catheters have been locked with a heparin solution in order to avoid occlusion. However, no scientific evidence supports heparin locking when the device is not in use. Advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. Therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.

Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters

Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial

Leuvens Kanker Instituut

Universitaire Ziekenhuizen KU Leuven

Marguerite Stas

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia	NCT00735813	Bacteremia Neoplasms	Taurolock Heparin	- 17 Years	Aarhus University Hospital
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia	NCT00735813	Bacteremia Neoplasms	Taurolock Heparin	- 17 Years	Aarhus University Hospital
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters	NCT00994136	Oncology, Medic... Hematologic Dis...	normal saline	1 Year -	Universitaire Ziekenhuizen KU Leuven
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters	NCT00994136	Oncology, Medic... Hematologic Dis...	normal saline	1 Year -	Universitaire Ziekenhuizen KU Leuven

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