Title: Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomized, non-inferiority, open trial
Authors: Goossens, Godelieve ×
Jérôme, Martine
Janssens, Christel
Peetermans, Willy
Fieuws, Steffen
Moons, Philip
Verschakelen, Johny
Jacquemin, Marc
Stas, Marguerite #
Issue Date: Jul-2013
Publisher: Kluwer Academic Publishers
Series Title: Annals of Oncology vol:24 issue:7 pages:1892-1899
Conference: Association of Vascular Access,Annual Meeting edition:26 location:San Antonio, TX, USA date:16-19 October 2012
Belgian Vascular Access Network location:Ohain, Belgium date:6 October 2012
Vlaamse vereniging voor Radiotherapie en Oncologieverpleegkunde edition:29 location:Blankenberge, Belgium date:17 November 2012
The Christie Vascular Access Symposium edition:1 location:Manchester, UK date:20 March 2013

Heparin has been used for years as a locking solution in totally implantable venous access devices. Normal saline (NS) might be a safe alternative for heparin. However, evidence of non-inferiority of NS versus heparin is lacking.


We randomly allocated 802 cancer patients with a newly inserted port either to heparin lock (300 U/3 ml) or to NS lock groups in a 1:1 assignment ratio. The primary outcome was the number of functional complications, which was defined as 'easy injection, impossible aspiration' at port access. Secondary outcomes included all functional problems and catheter-related bacteraemia. We hypothesised that NS locks do not cause more functional problems and catheter-related bacteraemia than heparin locks. Non-inferiority is established if the upper limit of the confidence interval (CI) for the relative risk of NS versus heparin is <1.4.


Three hundred and eighty-two patients from the NS group and 383 from the heparin lock group were included in the analysis. The incidence rate of our primary outcome (easy injection, impossible aspiration) was 3.70% (95% CI 2.91%-4.69%) and 3.92% (95% CI 3.09%-4.96%) of accesses in the NS and heparin groups, respectively. The relative risk was 0.94% (95% CI 0.67%-1.32%). Catheter-related bloodstream infection was 0.03 per 1000 catheter days in the NS group and 0.10 per 1000 catheter days in the heparin group.


NS is a safe and effective locking solution in implantable ports if combined with a strict protocol for device insertion and maintenance.
ISSN: 0923-7534
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Academic Centre for Nursing and Midwifery
Laboratory for Clinical Infectious and Inflammatory Disorders
Molecular and Vascular Biology
Surgical Oncology
Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat)
× corresponding author
# (joint) last author

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2013 Citation postprint Ann of onc Hep vs NS.pdfOA article Published 707KbAdobe PDFView/Open
2013 Goossens GA Hep vs normal saline final May 2013.pdfOA Published 430KbAdobe PDFView/Open


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