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.

Recruiting

• Conditions: centraal veneuze toegang; central line infections; central line-associated bloodstream infections; 10019815; 10027655

• Registration Number: NL-OMON55586
• Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 462

Inclusion Criteria

1. Age between 0 - <19 years
2. Radiological, cytological or histological proven paediatric malignancy
(hematologic, solid, and neurologic malignancies)
3. Hickman/powerline or totally implantable venous access port to be inserted
at the Princess Maxima Center
4. Planned central venous access device insertion of >90 days
5. Written consent signed according to local law and regulations
6. Parents/guardians or patient willing and able to comply with the trial
procedure

Exclusion Criteria

1. A previous CVAD removed <12 months ago.
2. Expected treatment for a majority of the time in a different hospital than
the Princess Maxima Center for pediatric oncology in the first 90 days of
inclusion resulting in difficulties/an inability to visit the Princess Maxima
Center at least once every 3 weeks.
3. Primary immunological disorder
4. Contra indications: hypersensitivity to taurolidine, citrate or heparin, and
a history of heparin-induced thrombocytopenia
5. Documented bacteremia in the period from 24h before catheter insertion until
inclusion.
6. Insertion of the central venous access device at the same site as a
previously confirmed central venous thrombosis
7. Pregnant, not willing to use adequate contraceptives, or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of first tunneled central line associated bloodstream infections<br /><br>(CLABSI) since the insertion of the central venous access device (CVAD). All<br /><br>data-points that are needed for the evaluation of the occurrence of a CLABSI<br /><br>will be collected by the local data-manager. Three experts will blindly and<br /><br>independently judge if a CLABSI or no-CLABSI occurred in all patient based on<br /><br>the collected data and the CLABSI definition. All non unanimous judgements<br /><br>will be discussed between the experts until they all agree. If the experts<br /><br>still disagree, the final judgement will be based on the judgement of the<br /><br>majority.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Time to first tunneled central line associated bloodstream infections (CLABSI)<br /><br>since the insertion of the central line (CVAD)<br /><br>CLABSI incidence per 1,000 CVAD-days<br /><br>Incidence of symptomatic central venous thrombosis (CVT)<br /><br>Incidence of bacteremia<br /><br>Incidence of local infections<br /><br>Dispense of thrombolysis/systemic antibiotic treatment due to CLABSI/CVT<br /><br>Incidence of and reasons for CVAD-removal<br /><br>Cultured microorganisms causing CLABSIs<br /><br>Days of hospital admission due to CLABSIs/CVTs<br /><br>Safety of the taurolidine-citrate-heparin/heparin lock in terms of known side<br /><br>effects, severe adverse events (SAEs), intensive care unit admission, and<br /><br>mortality rate due to CLABSIs/CVTs</p><br>