Journal Article

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

Ziafati, Makan, Ghasemi, Ali, Eghbali, Aziz, Obeidinia, Mobin, Ghaffari, Kazem, Shirani, Arya

2025

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Anemia / Anticoagulants / Anticoagulants - therapeutic use / Antimicrobial agents / Biofilms / Biomedicine / Blood cell count / Blood clot / C-reactive protein / C-Reactive Protein - metabolism / Cancer / Catheter dysfunction / Catheter-Related Infections - etiology / Catheter-Related Infections - prevention & control / Catheterization, Central Venous - adverse effects / Catheters / Central Venous Catheters - adverse effects / Chemotherapy / Child / Child, Preschool / Clinical trials / Consent / CRBSI / Drug delivery systems / Drugs / Female / Guardians / Health aspects / Heparin / Heparin - administration & dosage / Heparin - therapeutic use / Humans / Infant / Infection / Infectious Diseases / Interleukins / Internal Medicine / Lock therapy / Male / Malignancy / Medical prognosis / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Neoplasms - complications / Neoplasms - drug therapy / Neoplasms - therapy / Nosocomial infections / Oncology / Patients / Pediatrics / Prevention / Prospective Studies / Surgery / Taurine - administration & dosage / Taurine - analogs & derivatives / Taurine - therapeutic use / Taurolidine / Thiadiazines - administration & dosage / Thiadiazines - therapeutic use / Thrombosis / Thrombosis - etiology / Thrombosis - prevention & control / Vehicles