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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2023-12-01

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.

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Detailed Description

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Conditions

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Central Line-associated Bloodstream Infection (CLABSI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.

Heparin lock (heparin 100 IU/mL)

Group Type ACTIVE_COMPARATOR

Heparin lock (heparin 100 IU/mL)

Intervention Type DEVICE

The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.

Interventions

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

The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.

Intervention Type DEVICE

Heparin lock (heparin 100 IU/mL)

The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.

Intervention Type DEVICE

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

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No