search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Central line-associated bloodstream infection prevention using TauroLock-Hep100 in pediatric oncology patients.


- candidate number27835
- NTR NumberNTR6688
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2017
- Secondary IDs236593526 Prinses Maxima Centrum
- Public TitleCentral line-associated bloodstream infection prevention using TauroLock-Hep100 in pediatric oncology patients.
- Scientific TitleThe efficacy of a lock solution containing taurolidine, citrate and heparin for the prevention of tunnelled central line-associated bloodstream infections in pediatric oncology patients, a randomized controlled, mono-centre trial.
- ACRONYMCATERPILLAR
- hypothesisA decrease in the incidence of central line-associated bloodstream infections in the investigational study group, compared to the control group.
- Healt Condition(s) or Problem(s) studiedCentral vein catheter , Pediatric cancer patients, Bloodstream infection
- Inclusion criteriaAge between 0 - <19 years
Radiological, cytological or histological proven paediatric oncology (haematologic, solid, and neurologic malignancies)
Hickman-catheter / Powerline or totally implantable venous access port to be inserted at the Princess Maxima Center
Parents/guardians or patient are able to understand patient information and to comply with protocol procedures.
Written consent signed according to local law and regulations Willing and able to comply with the trial procedure
- Exclusion criteriaPrevious tunnelled central venous access device removed < 12 months
Primary immunological disorder
Contra indications: hypersensitivity to taurolidine, citrate or heparin, a history of heparin-induced thrombocytopenia.
Documented bloodstream infection at the time of catheter insertion
Insertion of the central venous access device at the same site as a previously confirmed central venous thrombosis.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2019
- planned closingdate1-mrt-2021
- Target number of participants412
- InterventionsPatients in the taurolidine, citrate and heparin lock study arm will receive a lock solution containing taurolidine 1.35%, citrate 4% and heparin 100 IU/ml (TauroLock™-Hep100). Patients in the heparin lock study arm will receive a lock solution containing the standard of care heparin 100 IU/ml.
The lock volume will depend on the central venous access device type, the central venous access device lumen needs to be filled completely. The locks will be instilled with a minimum of once every two weeks, and a maximum of once every week. The TauroLock-Hep100 will be aspirated and discarded before the instillation of a new lock. The heparin lock will be flushed into the bloodstream.
- Primary outcomeIncidence of first central line associated bloodstream infection
- Secondary outcomeTime to first CLABSI (since insertion of the CVAD)
Incidence of (a)symptomatic CVTs
Incidence of bacteraemia
Dispense of thrombolysis/systemic antibiotic treatment due to CLABSI or CVT
Incidence of and reasons for CVAD-removal.
Cultured microorganisms causing CLABSI.
Days of hospital admission due to CLABSI/CVT.
Safety of the TCHL/HL in terms of known side effects, SAEs, intensive care unit admission, and death due to CLABSI/CVT.
- TimepointsEvery CVAD will be followed up until first tunnelled CLABSI episode has been resolved (symptom free and/or negative blood cultures), removal of the CVAD, or death of the patient, whatever end-point will come first with a maximum study period of 90 days.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Ceder van den Bosch
- CONTACT for SCIENTIFIC QUERIES Ceder van den Bosch
- Sponsor/Initiator Princess Maxima Center for Pediatric Oncology
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryTunneled central venous access devices (CVAD) are fundamental in pediatric oncology for long-term venous access. The incidence of central line-associated bloodstream infections (CLABSI) is high and ranges between 0.1-2.3 per 1,000 CVAD-days. In the Princess Máxima Center for pediatric oncology, the incidence rate of CLABSI was 1.51 per 1,000 CVAD-days. Of all CVADs inserted, 17% were removed and 5% of the patients were admitted at an intensive care unit due to CLABSIs. Central venous thrombosis (CVT) is another severe complication of the CVAD, with an incidence rate of 0.02-0.24 per 1,000 CVAD-days. Different lock solutions are available to prevent the CVAD from CLABSIs and CVAD-related CVTs. In the Netherlands, the heparin lock (HL) is the standard of care. The HL however, does not have an antimicrobial activity and its use is barely supported by literature. Locks containing taurolidine and citrate, which have anticoagulant and antimicrobial activities without reported resistance to taurolidine, appear to be promising in the prevention of CLABSIs. The taurolidine-citrate(-heparin) lock solution (TCHL) was shown to decrease the CVAD-infection incidence by 53-100% in haemodialysis patients, total parenteral nutrition patients, and adult oncology patients. In pediatric oncology patients, four studies have been performed which only included a small number of patients (n≤180). Therefore, these studies did not deliver enough evidence to implement the TCHL in pediatric oncology patients. Due to the centralization of the pediatric oncology care in the Netherlands we are now able to perform an open labelled randomized controlled trial and include a large number of patients (n=412), so that we can finally draw conclusions on the efficacy and safety of the TCHL in pediatric oncology patients. Our goal is to reduce the CLABSI-rate, CVAD-removal rate, dispense of antibiotics, days of hospital/intensive care admission, and mortality rate due to CLABSI.
- Main changes (audit trail)
- RECORD7-sep-2017 - 20-okt-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl