The CATERPILLAR-study: An assessor blinded randomized controlled trial comparing a taurolidine-citrate-heparin lock solution to a heparin-only lock solution for the prevention of central-line associated bloodstream infections in paediatric oncology patients

Background: Taurolidine–citrate(–heparin) lock solutions (TCHL) are suggested as a promising and safe method for the prevention of central-line-associated bloodstream infections (CLABSI). Aim: To investigate the efficacy of TCHL for the prevention of CLABSI in paediatric oncology patients. Methods: An assessor-blinded randomized controlled trial at the Princess Máxima Centre for paediatric oncology, the Netherlands, was performed from 2020 to 2023. Paediatric oncology patients receiving a tunnelled central venous access device (CVAD) were eligible. A total of 462 patients were required to compare the TCHL to the heparin-only lock (HL). Patients were followed-up for the first 90 days after CVAD insertion. The primary outcome was the incidence of the first CLABSI from CVAD insertion until the end of follow-up. Intention-to-treat and per-protocol analyses were performed. Findings: In total, 232 were randomized in the HL and 231 in the TCHL group. A total of 47 CLABSIs were observed. The intention-to-treat analysis showed that a CLABSI was observed in 26 (11.2%) of the HL group patients versus 21 (9.1%) of the TCHL group patients; incidence rate ratio (IRR) of 0.81 (95% confidence interval (CI): 0.46–1.45) in favour of the TCHL group. The per-protocol analysis showed that a CLABSI was observed in 10 (7.9%) of the HL group patients versus 6 (4.8%) of the TCHL group patients; IRR of 0.59 (95% CI: 0.21–1.62) in favour of the TCHL group. Adverse events were more common in the TCHL group but rarely reported. Conclusion: No difference was detected between the TCHL and HL in the incidence of CLABSI in paediatric oncology patients.