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|Title:||Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial||Authors:||Goossens, G. A.
Peetermans, W. E.
|Issue Date:||2013||Publisher:||OXFORD UNIV PRESS||Source:||ANNALS OF ONCOLOGY, 24 (7), p. 1892-1899||Abstract:||Background: 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. Patients and methods: 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. Results: 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. Conclusion: NS is a safe and effective locking solution in implantable ports if combined with a strict protocol for device insertion and maintenance.||Notes:||[Goossens, G. A.; Jerome, M.; Janssens, C.] Univ Hosp Leuven, Nursing Ctr Excellence, B-3000 Louvain, Belgium. [Goossens, G. A.; Moons, P.] Katholieke Univ Leuven, Dept Publ Hlth & Primary Care, Louvain, Belgium. [Peetermans, W. E.] Univ Hosp Leuven, Dept Internal Med, B-3000 Louvain, Belgium. [Fieuws, S.] Katholieke Univ Leuven, Interuniv Ctr Biostat & Stat Bioinformat, Louvain, Belgium. [Fieuws, S.] Univ Hasselt, Interuniv Ctr Biostat & Stat Bioinformat, Hasselt, Belgium. [Verschakelen, J.] Univ Hosp Leuven, Dept Radiol, B-3000 Louvain, Belgium. [Peerlinck, K.; Jacquemin, M.] Katholieke Univ Leuven, Ctr Mol & Vasc Biol, Louvain, Belgium. [Stas, M.] Univ Hosp Leuven, Dept Surg Oncol, B-3000 Louvain, Belgium.||Keywords:||catheter lock; catheter-related infection; equipment failure; heparin; sodium chloride;catheter lock; catheter-related infection; equipment failure; heparin; sodium chloride||Document URI:||http://hdl.handle.net/1942/15459||ISSN:||0923-7534||e-ISSN:||1569-8041||DOI:||10.1093/annonc/mdt114||ISI #:||000321881600027||Category:||A1||Type:||Journal Contribution||Validations:||ecoom 2014|
|Appears in Collections:||Research publications|
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