Lotke 1999.
Study characteristics | ||
Methods |
Design: RCT, parallel 2‐arm, single‐site trial Setting: university hospital (Pennsylvania, USA) Recruitment: not specified Maximum follow‐up: 30 days |
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Participants | 127 participants undergoing primary TKA who elected to pre‐donate blood were randomly assigned to 1 of 2 groups
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Interventions |
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Outcomes | Complications, cardiac events, Hb, blood usage (units), mental confusion, lethargy, orthostatic hypotension, number of participants transfused | |
Notes |
Trial registration: none ascertainable Trial funding: none reported COI statement by investigators: no information reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Trial used a computer random number generator |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
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 participants and personnel was not specified |
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' Assessments were made by a person blinded to the group to which the participant was assigned |
Blinding of outcome assessment (detection bias) Subjective measures | Low risk | Assessments were made by a person blinded to the group to which the participant was assigned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data appear to have been complete |
Selective reporting (reporting bias) | Low risk | Evidence of prospective registration/trial protocol unavailable; insufficient information to make a judgement |
Other bias | Low risk | No other biases were apparent |