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

Christopoulou 2001.

Methods Design: Randomised controlled trial. 
 Setting: Single centre, Evangelismos Hospital, University of Athens, Greece.
Participants N = 48 patients undergoing maxillofacial operations.

  • PAD group (I) = M/F = 12/16, age 18‐45 years.

  • Control group (C) = M/F = 7/13, age 18‐45 years.


Baseline risk factors: haematocrit and red blood count levels of control group were significantly higher than of the intervention group. 
 Inclusion criteria: orthognathic surgery, reconstruction after trauma or removal of tumours, removal of benign tumours or malformations; anticipated need for blood not to exceed 4 units; completion of donor form; haematological testing donor‐recipient to be carried out. 
 Exclusion criteria: Hb greater than 11 g/dL; haematocrit less than 11 g/dL or 34%; anaemia; less than 10 years of age and greater than 65 years of age; active malignant tumour; coronary disease; recent MI; arterial hypertension (systolic blood pressure higher than 180 mmHg, diastolic blood pressure higher than 100 mmHg); pregnancy; AIDS; diabetes; active infection for which treatment being given.
Interventions

  • PAD group (n = 28)

  • Control (n = 20)

  • *PAD plus EPO


[*not included in the review's analysis]
Timing of autologous blood collection/retransfusion: blood donated at least one week before operation, time between donations was one week, retransfused intra‐operatively (PAD group only). 
 Volume of autologous blood collected/retransfused: 24 PAD patients pre‐donated 1 unit each and 4 patients predonated 2 units (bimaxillary osteotomies). 
 Iron supplementation: all patients received 150 mg ferrous sulphate daily by mouth pre‐operatively until 1 week postoperatively. 
 Use of transfusion threshold: no details 
 Length of surgery: no details
Outcomes Outcomes reported: number of patients exposed to allogeneic blood, number of patients exposed to autologous blood, pre‐operative Hb.
Notes Period of study: 1990‐1995 
 Length of study: 4 weeks. 
 A priori sample size: no
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Report states that 'consecutive patients randomly assigned'. No further information given.
Allocation concealment? Unclear risk No information.
Blinding? 
 All outcomes Unclear risk No information.
Intention‐to‐treat analysis? Unclear risk Insufficient information presented to judge whether data were analysed on an intention‐to‐treat basis.