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. 2021 Dec 21;2021(12):CD002042. doi: 10.1002/14651858.CD002042.pub5

Akyildiz 2018.

Study characteristics
Methods Design: RCT, parallel 2‐arm, single‐site, non‐inferiority, 'per‐protocol' approach
Setting: PICU, tertiary (university‐affiliated hospital), Kayseri, Turkey
Recruitment: January 2014 to December 2015
Maximum follow‐up: in‐hospital stay
Participants 180 children in paediatric ICU randomised; 160 completed follow‐up
  • Liberal group: n = 89; M/F 41/48; median (IQR) age = 36 (24 to 48) months

  • Restrictive group: n = 71; M/F 36/35; median (IQR) age = 72 (36 to 84) months

Interventions
  • Liberal group: Hb < 10 g/dL trigger

  • Restrictive group: Hb < 7 g/dL trigger

Outcomes Primary outcomes: cardiac output and other haemodynamic measures
Secondary outcome: in‐hospital mortality
Notes Trial registration: not confirmed. Internal (university) documentation: registration TSA‐2014‐5299
Trial funding/Sponsor: Erciyes University Scientific Research Unit
Conflict of interest: study authors declare they have none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "Randomization was provided by a coin toss" (Akyildiz 2018 p 2)
Allocation concealment (selection bias) High risk  
No information was provided beyond the statement above
 
Blinding of participants and personnel (performance bias)
Objective outcomes Low risk Blinding of personnel for this intervention is not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low'
Blinding of outcome assessment (detection bias)
Objective measures Low risk Blinding of mortality (the primary outcome used within this review) is not relevant, and we will grade risk of bias as 'low'
Blinding of outcome assessment (detection bias)
Subjective measures Low risk "Cardiologists who assessed the cardiac output measurements were blinded to treatment allocations" (Akyildiz 2018 p 2)
No other subjective outcomes were used in this review 
Incomplete outcome data (attrition bias)
All outcomes High risk There was a differential loss to follow‐up, with more losses in the restrictive arm (1 loss in the liberal arm and 19 in the other)
 
Selective reporting (reporting bias) Unclear risk No evidence of prospective registration; trial protocol unavailable; information insufficient to make a judgement
Other bias Low risk None apparent