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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Central Line-associated Bloodstream Infection (CLABSI)

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)<br> | Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)<br>* The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.<br>|
| Active Comparator: Heparin lock (heparin 100 IU/mL)<br> | Device: Heparin lock (heparin 100 IU/mL)<br>* The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first central line associated bloodstream infection |  | 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 symptomatic 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). | 
| 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). | 
| 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). | 
| Cultured microorganisms causing central line associated bloodstream infections |  | 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). | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Line-associated Bloodstream Infection, Paediatric oncology patients, Central venous access device