Methods | Allocation concealment was by means of sealed envelopes. The pharmacist prepared the encoded infusions. All study infusions were identical in outward appearance | |
Participants | 149 patients scheduled for elective coronary artery bypass graft surgery, heart valve replacement or annuloplasty, combined valve replacement and coronary artery bypass grafting, or closure of atrial septal defects were randomly assigned to one of three groups
NB: Three patients requiring re-operation due to bleeding related to the operation (one in the aprotinin group and two in the DDAVP group) were excluded from the final analysis |
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Interventions |
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Outcomes | Number of patients transfused allogeneic blood (n) Amount of allogeneic blood transfused (units) Number of patients transfused fresh frozen plasma (FFP) (n) Number of patients transfused platelets (n) Blood loss (ml) Mortality (n) Re-operation for bleeding (n) Femoral embolism (n) Stroke (n) |
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Notes | Quality assessment score (Schulz criteria): 4/7 Transfusion protocol used. |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Method of randomisation was not described. |
Allocation concealment? | No | C - Inadequate. Allocation concealment was by means of sealed envelopes |
Blinding? All outcomes |
Yes | Double blind. |