Shehata 2012.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, open‐label, single‐site pilot trial Setting: university teaching hospital, Toronto, Canada Recruitment: January 2007 to June 2010 Maximum follow‐up: 30 days |
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Participants | 50 adult participants undergoing cardiac surgery with a CARE score (a score for cardiac surgery participants used to predict morbidity and mortality) of 3 or 4, or participants of advanced age defined as ≥ 80 years
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Interventions |
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Outcomes | Primary outcome: enrolment rate and overall adherence to transfusion strategies (pilot study). Clinical outcomes were assessed | |
Notes |
Trial title: Transfusion Triggers in Cardiac Surgery Trial registration (not prospective; record posted 6 months after trial start): NCT00470444 Trial funding: this trial was supported by Canadian Blood Services SPF XT00070. Canadian Blood Services as a funding agency had no role in the design and conduct of the trial COI statement by investigators: "the authors declare that they have no conflicts of interest relevant to the manuscript submitted to TRANSFUSION" (Shehata 2012 p 97) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | An independent statistician generated the allocation sequence |
Allocation concealment (selection bias) | Low risk | Opaque sequential sealed envelopes were opened at the start of surgery |
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' Clinicians and participants were not blinded |
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 from subjective outcomes (e.g. function) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data appeared complete for all 50 participants |
Selective reporting (reporting bias) | Low risk | This pilot trial was registered 6 months after recruitment began. All expected outcomes for a pilot were reported |
Other bias | Low risk | No other biases were apparent |