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

Not Applicable

Recruiting

• Conditions: Central Line-associated Bloodstream Infection (CLABSI)
• Interventions: Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL); Device: Heparin lock (heparin 100 IU/mL)

• Registration Number: NCT05740150
• Lead Sponsor: Princess Maxima Center for Pediatric Oncology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 462

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)	TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)	-
Heparin lock (heparin 100 IU/mL)	Heparin lock (heparin 100 IU/mL)	-

Primary Outcome Measures

Name	Time	Method
Incidence of central line associated bloodstream infections	From central venous access device insertion until the end of follow-up (maximum of 90 days).

Secondary Outcome Measures

Name	Time	Method
Time to first central line associated bloodstream infection	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of symptomatic central venous thrombosis	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Central line associated bloodstream infection incidence per 1,000 central venous access device-days	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of and reasons for central venous access device-removal	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of bacteraemia	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Incidence of local infections	From central venous access device insertion until the end of follow-up (maximum of 90 days).
Cultured microorganisms causing central line associated bloodstream infections	From central venous access device insertion until the end of follow-up (maximum of 90 days).

Trial Locations

Locations (1)

Princess Máxima Center for Pediatric Oncology; 🇳🇱 Utrecht, Netherlands