Clinical trial · Interventional
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Line-associated Bloodstream Infection (CLABSI) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heparin lock (heparin 100 IU/mL) | Device | — | UNRESOLVED |
| TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
- interventionNames
- Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
- type
- ACTIVE_COMPARATOR
- label
- Heparin lock (heparin 100 IU/mL)
- interventionNames
- Device: Heparin lock (heparin 100 IU/mL)
Primary outcomes (1)
- 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 (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDvan den Bosch CH, Loeffen Y, van der Steeg AFW, van der Bruggen JT, Frakking FNJ, Fiocco M, van de Ven CP, Wijnen MHWA, van de Wetering MD. CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients. BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760. PMID 36944461