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

Trial Title: Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

NCT ID: NCT05740150

Condition: Central Line-associated Bloodstream Infection (CLABSI)

Conditions: Official terms:
Infections
Communicable Diseases
Sepsis
Taurolidine
Heparin
Calcium heparin

Conditions: Keywords:
Central Line-associated Bloodstream Infection
Paediatric oncology patients
Central venous access device

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)
Description: The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Arm group label: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)

Intervention type: Device
Intervention name: Heparin lock (heparin 100 IU/mL)
Description: The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.
Arm group label: Heparin lock (heparin 100 IU/mL)

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 0 Years

Maximum age: 18 Years

Healthy volunteers: No

Locations:

Facility:
Name: Princess Máxima Center for Pediatric Oncology

Address:
City: Utrecht
Zip: 3511XK
Country: Netherlands

Status: Recruiting

Contact:
Last name: Ceder van den Bosch, MSc

Phone: +31625395632
Email: c.h.vandenbosch-4@prinsesmaximacentrum.nl

Start date: October 27, 2020

Completion date: December 1, 2023

Lead sponsor:
Agency: Princess Maxima Center for Pediatric Oncology
Agency class: Other

Collaborator:
Agency: Dutch Cancer Society
Agency class: Other

Collaborator:
Agency: UMC Utrecht
Agency class: Other

Source: Princess Maxima Center for Pediatric Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05740150