Impact of TauroLock™-HEP500 versus unfractionated heparin for prevention of catheter complications in children with malignancy: a prospective, randomized, controlled study.

BACKGROUND AND AIMS: Central venous catheters (CVCs) are essential for drug delivery in pediatric oncology patients but are associated with complications such as infection and thrombosis. This study aimed to compare the effects of taurolidine-citrate and unfractionated heparin lock solutions on catheter function, infection and thrombosis rates, and inflammatory markers in children with malignancies. METHODS: In this randomized, controlled trial, 76 pediatric oncology patients were allocated to receive either TauroLock™-HEP500 (containing taurolidine, 4% citrate, and 500 IU/mL heparin) or standard unfractionated heparin as the catheter lock solution. Patients were followed for 6 months. Laboratory evaluations, including complete blood count (CBC), high-sensitivity C-reactive protein (hs-CRP), and interleukin-6 (IL-6), were performed at baseline, 1 month, and 6 months, or upon clinical suspicion of infection. RESULTS: At 6 months, hs-CRP levels were significantly lower in the taurolidine-citrate group (2.1 ± 0.2 vs. 5.5 ± 2.2, p = 0.001), as was total WBC count (3792.1 ± 325.3 vs. 4994.5 ± 462.1, p = 0.028). IL-6 levels showed no statistically significant difference (9.2 ± 1.9 vs. 14.0 ± 3.1, p = 0.067). The incidence of catheter-related infections (HR 3.55, 95% CI 0.68-18.4, p = 0.460) and thrombosis (HR 4.13, 95% CI 0.43-39.91, p = 0.221) did not differ significantly between groups. CONCLUSION: Taurolidine-citrate exhibited a modest anti-inflammatory effect, reflected by reduced hs-CRP and WBC levels, without significant improvement in catheter-related complications or IL-6. The lack of major clinical benefit may relate to the heterogeneous and immunocompromised nature of pediatric oncology patients. Larger, adequately powered studies are warranted to clarify the long-term efficacy and safety of taurolidine-citrate in this population. Clinical Trials as IRCT20201107049296N4.