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.
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.
  
  
  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.
  
  
  CONCLUSIONS
  NS is a safe and effective locking solution in implantable ports if combined with a strict protocol for device insertion and maintenance.
authors.affiliation: Nursing Centre of Excellence, University Hospitals Leuven, Leuven; Department of Public Health and Primary Care, KU Leuven, Leuven. Electronic address: godelieve.goossens@uzleuven.be.
authors.forename: G A
authors.initials: GA
authors.lastname: Goossens
authors.affiliation: Nursing Centre of Excellence, University Hospitals Leuven, Leuven.
authors.forename: M
authors.initials: M
authors.lastname: Jérôme
authors.affiliation: Nursing Centre of Excellence, University Hospitals Leuven, Leuven.
authors.forename: C
authors.initials: C
authors.lastname: Janssens
authors.affiliation: Department of Internal Medicine, University Hospitals Leuven, Leuven.
authors.forename: W E
authors.initials: WE
authors.lastname: Peetermans
authors.affiliation: Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU Leuven, Leuven; Interuniversity Centre for Biostatistics and Statistical Bioinformatics, Universiteit Hasselt, Hasselt.
authors.forename: S
authors.initials: S
authors.lastname: Fieuws
authors.affiliation: Department of Public Health and Primary Care, KU Leuven, Leuven.
authors.forename: P
authors.initials: P
authors.lastname: Moons
authors.affiliation: Department of Radiology, University Hospitals Leuven, Leuven.
authors.forename: J
authors.initials: J
authors.lastname: Verschakelen
authors.affiliation: Centre for Molecular and Vascular Biology, KU Leuven, Leuven.
authors.forename: K
authors.initials: K
authors.lastname: Peerlinck
authors.affiliation: Centre for Molecular and Vascular Biology, KU Leuven, Leuven.
authors.forename: M
authors.initials: M
authors.lastname: Jacquemin
authors.affiliation: Department of Surgical Oncology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Stas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016470:Bacteremia / Q000209:etiology; D055499:Catheter-Related Infections / Q000209:etiology; D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000379:methods*; D002408:Catheters, Indwelling / Q000382:microbiology; D005260:Female; D006493:Heparin / Q000737:chemistry*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D012965:Sodium Chloride / Q000737:chemistry*; D012996:Solutions; D055815:Young Adult
chemical_list: D012996:Solutions; D012965:Sodium Chloride; D006493:Heparin
keywords: catheter lock; catheter-related infection; equipment failure; heparin; sodium chloride