Clinical trial NCT05740150: Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Keywords: Central Line-associated Bloodstream Infection
Paediatric oncology patients
Central venous access device
Lead sponsor: Princess Maxima Center for Pediatric Oncology
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: UMC Utrecht
First posted: 2023-02-22
Enrollment: 462
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Incidence of central line associated bloodstream infections
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Secondary outcomes:
measure: Time to first central line associated bloodstream infection
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Central line associated bloodstream infection incidence per 1,000 central venous access device-days
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Incidence of symptomatic central venous thrombosis
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Incidence of bacteraemia
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Incidence of local infections
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Incidence of and reasons for central venous access device-removal
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Cultured microorganisms causing central line associated bloodstream infections
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
measure: Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis
timeFrame: From central venous access device insertion until the end of follow-up (maximum of 90 days).
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Princess Máxima Center for Pediatric Oncology
Study officials:
References: