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Recruiting
NCT05740150
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Sex: All
Ages: 0 Years – 18 Years
Phase: NA
Enrollment: 462
Sponsor: Princess Maxima Center for Pediatric Oncology
Location: Netherlands
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age between 0 - <19 yearsRadiological, 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 OncologyPlanned central venous access device insertion of >90 daysWritten consent signed according to local law and regulationsParents/guardians or patient are willing and able to comply with the trial procedureExclusion 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 disorderContra 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
Source: ClinicalTrials.gov (NCT05740150). StuddyBuddy aggregates publicly available trial information.