Skip to main content
. 2021 Dec 21;2021(12):CD002042. doi: 10.1002/14651858.CD002042.pub5

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
Participants 127 participants undergoing primary TKA who elected to pre‐donate blood were randomly assigned to 1 of 2 groups
  • Liberal group: n = 65; M/F = 19/46; mean age = 69.7 years

  • Restrictive group: n = 62; M/F = 20/42; mean age = 68.7 years

Interventions
  • Liberal group: transfused with autologous blood immediately after TKA, beginning in the recovery room postoperatively

  • Restrictive group: transfused with autologous blood when Hb had fallen to < 9.0 g/dL

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
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