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

Hébert 1999.

Study characteristics
Methods Design: RCT, parallel 2‐arm, multicentre trial
Setting: 22 tertiary‐level and 3 community ICUs in Canada
Recruitment: November 1994 to November 1997
Maximum follow‐up: 30 days
Participants 838 critically ill participants with euvolaemia after initial treatment and with Hb < 9.0 g/dL within 72 hours after admission to the ICU were randomly assigned to 1 of 2 groups:
  • Liberal group: n = 420; M/F = 255/165; mean (SD) age = 58.1 (18.3) years

  • Restrictive group: n = 418; M/F = 269/149; mean (SD) age = 57.1 (18.1) years

Interventions
  • Liberal group: transfused when Hb fell to < 10.0 g/dL. Hb maintained between 10.0 g/dL and 12.0 g/dL

  • Restrictive group: transfused if Hb dropped to < 7.0 g/dL. Hb was maintained between 7.0 g/dL and 9.0 g/dL

Outcomes Mortality, length of hospital stay, length of ICU stay, blood usage (units), complications, infection rates, cardiac events, pulmonary oedema, pneumonia
Notes Trial registration: none ascertainable
Trial funding: supported by the Medical Research Council of Canada and by an unrestricted grant from Bayer
COI statement by investigators: published paper included no information
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The random order was computer generated (Hébert 1999 p 410)
Allocation concealment (selection bias) Low risk "The data coordinating centre prepared sealed opaque envelopes, which they distributed to each participating institution where they were opened up sequentially to determine the participants treatment assignment. The envelopes were returned periodically to the coordinating centre for auditing" (Hébert 1999 p 410)
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 graded risk of bias as 'low'
"It was not feasible to mask the assigned transfusion strategy from health care providers"
Participants were ICU patients. Most outcomes were based on laboratory measures 
Blinding of outcome assessment (detection bias)
Subjective measures Low risk No data from subjective outcomes (e.g. function)
Incomplete outcome data (attrition bias)
All outcomes Low risk Of 838 participants randomised, there were 4 withdrawals from the liberal transfusion arm and 5 from the restrictive arm
Selective reporting (reporting bias) Unclear risk Evidence of prospective registration/trial protocol unavailable; insufficient information available to make a judgement
Other bias Low risk No other biases were apparent