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

NCT05740150 | Unknown DMC

• 3 other identifiers: NL2365.041.26NTR66812617
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Line-associated Bloodstream Infection (CLABSI)

Keywords

Central Line-associated Bloodstream Infection; Paediatric oncology patients; Central venous access device

Outcome Measures

Primary Outcomes (1)

• Incidence of central line associated bloodstream infections

  From central venous access device insertion until the end of follow-up (maximum of 90 days).

Secondary Outcomes (10)

• 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).

Study Arms (2)

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

EXPERIMENTAL

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

Heparin lock (heparin 100 IU/mL)

ACTIVE COMPARATOR

Device: Heparin lock (heparin 100 IU/mL)

Interventions

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

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

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

Heparin lock (heparin 100 IU/mL) DEVICE

The Heparin lock 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)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• A previous central venous access device removed \< 12 months ago.
• Primary immunological disorder
• Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.

Sponsors & Collaborators

• Princess Maxima Center for Pediatric Oncology: lead
• Dutch Cancer Society: collaborator
• UMC Utrecht: collaborator

Study Sites (1)

Princess Máxima Center for Pediatric Oncology

Utrecht, 3511XK, Netherlands

RECRUITING

Related Publications (1)

• van den Bosch CH, Loeffen Y, van der Steeg AFW, van der Bruggen JT, Frakking FNJ, Fiocco M, van de Ven CP, Wijnen MHWA, van de Wetering MD. CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients. BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760.

  PMID: 36944461 DERIVED

MeSH Terms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Central Study Contacts

Ceder H van den Bosch, MSc

CONTACT

+31625395632; c.h.vandenbosch-4@prinsesmaximacentrum.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 22, 2023
• Study Start: October 27, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before the end of the study the study protocol, statistical analysis plan and informed consent forms will be published in a peer-reviewed journal. The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.

Locations

NL (1)