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. 2018 Apr 3;2018(4):CD010597. doi: 10.1002/14651858.CD010597.pub2

CHARTS 2008.

Methods
  • Study design: quasi‐RCT

  • Study duration: December 2004 to June 2005

  • Duration of follow‐up: not reported

Participants
  • Setting: single centre

  • Country: Canada

  • Participants receiving chronic HD 3 times/week, 4 h/session, at the in‐centre HD Unit with cuffed catheters as primary vascular access; enrolled in the study until their catheters were removed or until the study completion date

  • Number (patients/catheters): treatment group (32/32); control group (29/29)

  • Mean age ± SD (years): treatment group (63 ± 16); control group (69 ± 15)

  • Sex (M/F): treatment group (21/11); control group (14/15)

  • Exclusion criteria: previously randomised to the study; AV fistula or AV graft was already in use at the time of the study; currently on antibiotics; unable or unwilling to give informed consent

Interventions Treatment group
  • Citrate: 4%


Control group
  • Heparin: 5000 U/mL

Outcomes
  • CRI

  • Exit side Infection

  • Local bleeding

  • Systemic bleeding complication (epistaxis, fistula hematoma, prolonged fistula bleeding 30 min, hemarthrosis, gastrointestinal bleeding, haemoptysis, and intracerebral haemorrhage)

  • Thrombocytopenia

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were randomised according to their last name
Allocation concealment (selection bias) High risk No allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk This was an open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk This was an open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data was reported
Selective reporting (reporting bias) Low risk Describes the outcome according to protocol
Other bias Unclear risk Funding source not reported