Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients. (CATERPILLAR)

Princess Maxima Center for Pediatric Oncology

Status: Enrolling

Conditions: Central Line-associated Bloodstream Infection (CLABSI)

Treatments: Device: Heparin lock (heparin 100 IU/mL); Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05740150

NTR668 (Registry Identifier)

12617 (Other Grant/Funding Number)

NL2365.041.26

Details and patient eligibility

About

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.

Enrollment: 462 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

462 participants in 2 patient groups

TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)

Experimental group

Treatment:

Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)

Heparin lock (heparin 100 IU/mL)

Active Comparator group

Treatment:

Device: Heparin lock (heparin 100 IU/mL)