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. 2001 Oct 23;2001(4):CD003602. doi: 10.1002/14651858.CD003602

Elawad 1991.

Methods Design: Randomised controlled trial. 
 Setting: Malmo General Hospital, Sweden.
Participants N = 60 patients undergoing elective primary total hip replacement.
  • *PAD = n = 15, M/F = 6/9; mean age = 71 years (range 62‐79)

  • *PAD + iron supplementation = n = 15, M/F = 7/8, mean age 71 years (range 60‐82)

  • *PAD + iron and folic acid supplementation = n = 15, M/F = 8/7; mean age 70 years (range 60‐81)

  • No PAD = n = 15, M/F = 6/9; mean age = 71 years (range 60‐81)


[*data for these groups were combined for the review's analysis to create one PAD group]
Interventions
  • PAD (n = 45)

  • Control group (n = 15)


Timing of autologous blood collection/retransfusion: Donated 31 to 40 days before operation, with nine to 16 days between each phlebotomy. 
 Volume of autologous blood collected/retransfused: Each donated on average between 2.8 and 3.0 units. 
 Iron supplementation: Two of the four groups were exposed to iron supplementation. One of these received iron supplementation as ferrous sulfate 100 mg three times daily, starting after the first phlebotomy, and the other received the iron supplementation plus folate supplementation as folate 5 mg three times daily, starting after the first phlebotomy. 
 Use of transfusion threshold: Not mentioned.
Outcomes Outcomes reported: Number of patients exposed to allogeneic blood (n), allogeneic blood transfused (units), blood loss (mL), deep vein thrombosis (n), pulmonary embolus (n), biochemical parameters.
Notes Period of study: January 1988 to February 1989 
 Length of study: Not reported. 
 A priori sample size: Not reported. 
 Baseline comparability: Age and gender of the patients were similar in all groups. Operation time (mean ± SD) was longer in the no‐PAD control group (125 ± 18) than the PAD groups (116 ± 19; 116 ± 26; 109 ± 20).
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk No information.
Allocation concealment? Unclear risk Patients were allocated by means of sealed envelopes
Blinding? 
 All outcomes Unclear risk No information.
Intention‐to‐treat analysis? Unclear risk No information.