Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Onco… (NCT05740150) | Clinical Trial Compass
UnknownNot Applicable
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
Netherlands462 participantsStarted 2020-10-27
Plain-language 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.
Who can participate
Age range0 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incidence of central line associated bloodstream infections
Timeframe: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Trial details
NCT IDNCT05740150
SponsorPrincess Maxima Center for Pediatric Oncology