Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

The Efficacy of a Lock Solution Containing Taurolidine, Citrate and Heparin for the Prevention of Tunneled Central Line-associated Bloodstream Infections in Pediatric Oncology Patients, a Randomized Controlled, Mono-center Trial.

The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.

Inclusion Criteria:

• Age between 0 - <19 years
• Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies)
• Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology
• Planned central venous access device insertion of >90 days
• Written consent signed according to local law and regulations
• Parents/guardians or patient are willing and able to comply with the trial procedure

Exclusion Criteria:

• A previous central venous access device removed < 12 months ago.
• Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks.
• Primary immunological disorder
• Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.
• Documented bacteremia in the period from 24h before catheter insertion until inclusion