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

Bush 1997.

Study characteristics
Methods Design: RCT, parallel 2‐arm, single‐site trial
Setting: university teaching hospital, Sacramento CA, USA
Recruitment: August 1995 to November 1996
Maximum follow‐up: in‐hospital stay
Participants 99 participants undergoing elective aortic or infrainguinal arterial reconstruction were randomised to 1 of 2 groups:
  • Liberal group: n = 49; M/F = 41/8; mean (SD) age = 64 (11) years

  • Restrictive group: n = 50; M/F = 32/18; mean (SD) age = 66 (10) years

Interventions
  • Liberal group: had Hb maintained at or > 10.0 g/dL

  • Restrictive group: transfused only when Hb fell to < 9.0 g/dL

Outcomes Primary endpoints: myocardial ischaemia, myocardial infarction, death during hospitalisation
Secondary endpoints: length of ICU stay, hospital stay, graft patency
Notes Trial registration: none confirmed
Trial funding: not reported
COI statement by investigators: none reported 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk  
"Sealed envelopes were chosen at random for participant assignment" (Bush 1997 p 144)
 
Allocation concealment (selection bias) Low risk Sealed envelopes were chosen at random for participant assignment
Blinding of participants and personnel (performance bias)
Objective outcomes Low risk Blinding of personnel for this intervention was not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we have 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 graded risk of bias as 'low'
Blinding of outcome assessment (detection bias)
Subjective measures Low risk No data on subjective outcomes (e.g. function) 
Review authors' judgement: low risk of bias
 
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcome data appeared to be complete
Selective reporting (reporting bias) Unclear risk No reporting bias was apparent, but in the absence of prospective registration or a trial protocol, assessment must remain 'unclear' 
 
Other bias Low risk No other biases identified