Methods | Patients were randomly assigned to one of two patient groups according to a system which used a series of sealed envelopes. The method of generating allocation sequences was not described | |
Participants | 70 patients undergoing various cardiac operations requiring cardiopulmonary bypass (CPB) were
randomly assigned to one of two groups
NB: One patient died in the operating room before receiving the study drug, and a second was withdrawn from the study at the request of the surgeon after randomisation but before treatment with the study drug. Neither of these patients were included in the analysis of the data |
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Interventions |
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Outcomes | Amount of allogeneic blood transfused (units) Blood loss (ml) Mortality (n) Myocardial infarction (n) Re-operation for bleeding (n) Cardiac arrest (n) Stroke (n) |
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Notes | Quality assessment score (Schulz criteria): 4/7 Transfusion protocol not specified. |
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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 |
Blinding? All outcomes |
Yes | Double blind. |