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:
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| 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 |
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| 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 |