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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20136

Enrollment

462

Registered

2017-09-07

Start date

2020-10-27

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central line associated bloodstream infection Central venous thrombosis Pediatric oncology

Interventions

Patients in the taurolidine, citrate and heparin lock study arm will receive a lock solution containing taurolidine 1.35%, citrate 4% and heparin 100 IU/ml (TauroLock™-Hep100). Patients in the heparin

Eligibility

Age

No minimum to 17 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Incidence of first central line associated bloodstream infection	—

Secondary

Measure	Time frame
Time to first tunneled Central Line Associated Bloodstream Infection (CLABSI) since the insertion of the Central Venous Access Device (CVAD) CLABSI incidence per 1,000 CVAD-days Incidence of (a)symptomatic Central Venous Thromboses (CVTs) Incidence of bacteremia Dispense of thrombolysis/systemic antibiotic treatment due to CLABSIs/CVTs Incidence of and reasons for CVAD-removal Cultured microorganisms causing CLABSIs Days of hospital admission due to CLABSIs/CVTs Safety of the study locks in terms of known side effects, liver enzymes, severe adverse events (SAEs), intensive care unit admission, and mortality rate due to CLABSIs/CVTs	—

Measure

Time frame

Time to first tunneled Central Line Associated Bloodstream Infection (CLABSI) since the insertion of the Central Venous Access Device (CVAD) CLABSI incidence per 1,000 CVAD-days Incidence of (a)symptomatic Central Venous Thromboses (CVTs) Incidence of bacteremia Dispense of thrombolysis/systemic antibiotic treatment due to CLABSIs/CVTs Incidence of and reasons for CVAD-removal Cultured microorganisms causing CLABSIs Days of hospital admission due to CLABSIs/CVTs Safety of the study locks in terms of known side effects, liver enzymes, severe adverse events (SAEs), intensive care unit admission, and mortality rate due to CLABSIs/CVTs

—

Contacts

Public ContactCeder van den Bosch

Princess Maxima Center for Pediatric Oncology

C.H.vandenBosch-4@prinsesmaximacentrum.nl+31625395632

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)