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. 2022 Jul 18;2022(7):CD008462. doi: 10.1002/14651858.CD008462.pub4

Goosens 2013.

Study characteristics
Methods Design: RCT, open‐label, non‐inferiority
Exclusions post‐randomisation: heparin group: n = 15; saline group: n = 22
Losses to follow‐up: heparin group: n = 211; saline group: n = 225
Duration of study: patient inclusion occurred from 23 January 2009 to 7 December 2010. Follow‐up lasted until 5 June 2011.
Unit of randomisation: participant
Participants Country: Belgium
Setting: oncology patients at hospital
Number: 802 (heparin group: n = 398; saline group: n = 404)
Age: heparin group: 54.9 ± 16.6; saline group: 56.7 ± 14.8
Sex: heparin group: male/female 135/263; saline group: male/female 143/261
Inclusion criteria: older than 1 year, scheduled for a first TIVAD insertion through the SVC system, had an onco‐haematological malignancy, and had a sufficient life expectancy to complete the planned follow‐up of 180 days in the study centre
Exclusion criteria: adult patients who were unable to sign informed consent, inability to stand for a postoperative chest X‐ray, patients with therapeutic intravenous heparin administration, history of HIT or abnormal clotting tests (international normalised ratio > 2, or platelet count < 40,000/mm3 or > 1,000,000/mm3), or coincident participation in other clinical trials
Interventions Locking with:
  • 3 mL heparin (100 IU/mL) after 10 mL 0.9% NaCl

  • 10 mL 0.9% NaCl

Outcomes Primary outcome: withdrawal occlusion at access (i.e. inability to aspirate blood while injection is easy)
Secondary outcomes: catheter‐related bacteraemia within 180 days, duration of catheter
Follow‐up: 180 days
Funding Partially funded by Leuvens Kankerinstituut and by BBraun Belgium
Declarations of interest Quote "GA. Gossens, M. Jérôme, and M. Stas have received speaking honoraria from BBraun. M. Stas has received educational research grants from BBraun and Opus medical. GA. Gossens has received travel grants from Opus medica. IM. Jérôme from BBraun and Opus Medical, C. Janssens from BBraun, Medri, and M. Stas from BBraun and CR Bard. M. Stas has been a consultant of BBraun. The remaining authors have declared no conflicts of interests."
Notes Additional raw data provided by trialists was used in the analysis.
3.5% of the patients were younger than 18 years.
Additional information about occlusions per participant was provided by the trialists.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised random number generation
Allocation concealment (selection bias) Low risk Allocation concealment by means of sequentially numbered participant cards, stored in a separate room
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Open label study. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Open label study. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Reporting of attrition/exclusions insufficient to permit judgement: no information on number of catheters losing patency in each group
Selective reporting (reporting bias) Low risk NCT00994136: all outcomes available
Other bias Unclear risk No separate analyses for children (3.5%) and adults. Not enough information to permit judgement of other bias