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 |
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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:
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Interventions |
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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 |
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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 |