Table 1.

Items from the WHO trial registration data set

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov, NCT05740150
Date of registration in primary registry	07-09-2017
Secondary identifying numbers	NTR6688 Netherlands Trial Register 12617 Dutch Cancer Society
Source(s) of monetary or material support	Monetary: Dutch Cancer Society (KWF) Material: Cablon Medical and TauroPharm
Primary sponsor	Princess Máxima Centre for Paediatric Oncology
Secondary sponsor(s)	Not applicable
Contact for public queries	Ceder Hildegard van den Bosch C.H.vandenBosch-4@prinsesmaximacentrum.nl +31625395632
Contact for scientific queries	Ceder Hildegard van den Bosch C.H.vandenBosch-4@prinsesmaximacentrum.nl +31625395632
Public title	Central line-associated bloodstream infection prevention using TauroLock-Hep100 in paediatric oncology patients.
Scientific title	The efficacy of a lock solution containing taurolidine, citrate and heparin for the prevention of tunnelled central line-associated bloodstream infections in paediatric oncology patients, a randomised controlled, monocentre trial.
Countries of recruitment	The Netherlands
Health condition(s) or problem(s) studied	Central line-associated bloodstream infections
Intervention(s)	Experimental: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) Active Comparator: Heparin lock (heparin 100 IU/mL)
Key inclusion and exclusion criteria	Inclusion criteria: Age between 0 and <19 years Radiological, cytological or histological proven paediatric malignancy (hematologic, solid and neurological malignancies) Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Centre for Paediatric 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 Centre for paediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Centre at least once every 3 weeks. Primary immunological disorder Contra indications: known hypersensitivity to taurolidine, citrate or heparin and a history of heparin-induced thrombocytopaenia Documented bacteraemia in the period from 24 hours before catheter insertion until inclusion Insertion of the central venous access device at the same site as a previously confirmed central venous thrombosis Pregnant, not willing to use adequate contraceptives or breast feeding
Study type	Interventional Allocation: Randomised in 2 arms 1:1 Masking: Assessor blinded Primary purpose: Prevention
Date of first enrolment	27-10-2020
Target sample size	462
Recruitment status	Recruiting
Primary outcome(s)	Incidence of central line-associated bloodstream infections
Key secondary outcomes	Time to first central line-associated bloodstream infection Central line-associated bloodstream infection incidence per 1000 central venous access device days Incidence of symptomatic central venous thrombosis Incidence of bacteraemia Incidence of local infections Dispense of thrombolysis/systemic antibiotic treatment due to central line-associated bloodstream infections/central venous thrombosis Incidence of and reasons for central venous access device removal Cultured micro-organisms causing central line-associated bloodstream infections Days of hospital admission due to central line-associated bloodstream infections/central venous thrombosis 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