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

Bracey 1999.

Study characteristics
Methods Design: RCT, parallel 2‐arm, single‐site trial
Setting: non‐profit research/treatment centre, Houston, TX, USA
Recruitment: February to November 1997
Maximum follow‐up: in‐hospital stay
Participants 428 consecutive participants undergoing elective primary coronary artery bypass graft surgery, randomly assigned to 1 of 2 groups:
  • Liberal group: n = 212; M/F 82/18; mean (SD) age = 61 (11) years

  • Restrictive group: n = 216; M/F 83/17; mean (SD) age = 62 (11) years

Interventions
  • Liberal group: received transfusions on the instructions of their individual physicians, who considered clinical assessment of the participant and institutional guidelines, which proposed a Hb < 9.0 g/dL as the postoperative threshold for RBC transfusion

  • Restrictive group: received an RBC transfusion in the postoperative period at Hb < 8.0 g/dL

Outcomes Mortality, length of hospital stay, blood usage (units), blood loss, complications, infection rates, cardiac events
Notes Trial registration: not confirmed
Trial funding: not reported
COI statement by investigators: none provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants "were randomly assigned on the basis of the last digit of their medical record number" (Bracey 1999 p 1071)
Review authors' judgement: this is not a genuinely random method of allocation. High risk of bias
Allocation concealment (selection bias) High risk Sequence generation (record number) obviated concealment of any kind
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 grade risk of bias as 'low'
Blinding of outcome assessment (detection bias)
Subjective measures High risk Investigators provided no information regarding the survey questionnaire
"When analyzed by Hb content, FACT‐F and FACT‐An scores were significantly different on postoperative Day 5, when patients with a Hb <9 g per dL were compared with patients with a Hb level >10 g per dL (p = 0.004). However, the same groups had similar survey scores on postoperative Day 3. Because the goal of our study was to maintain Hb content at >8 g per dL, we reanalyzed the subgroup and excluded patients with lowest Hb <8 g per dL. Then, survey scores did not differ significantly between low and high Hb groups...." (Bracey 1999 p 1075)
Incomplete outcome data (attrition bias)
All outcomes Low risk The trial used intention‐to‐treat analysis. Mortality data were reported for all participants, but for analysis of transfusion, participants who died during hospitalisation were excluded from analysis, as "early death precludes observation of transfusion and morbidity rate" (Bracey 1999 p 1075)
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 None identified