Methods | A table of random numbers determined patient allocation. Coded infusion bags and sealed envelopes were prepared by a pharmacist not involved in the study | |
Participants | 163 patients undergoing elective coronary revascularisation, valve replacement, both procedures, or repair of atrial septal defects were randomly assigned to one of four groups
NB: Data for gender not reported. Four patients were excluded from the final analysis (one from the placebo group, one from the TXA group, one from the DDAVP group, and one from the TXA + DDAVP group) |
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Interventions |
NB: Both groups were exposed to cell salvage, if available. One patient in the placebo group received pre-operative autologous blood (PAD) |
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Outcomes | Number of patients transfused allogeneic blood (n) Number of patients transfused fresh frozen plasma (n) Number of patients transfused platelets (n) Blood loss (ml) Myocardial infarction (n) Stroke (n) Deep vein thrombosis (n) Re-operation for bleeding (n) Ventricular dysfunction (n) Pulmonary dysfunction (n) Cardiac arrhythmia (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? | Yes | Randomisation was by means of a table of random numbers. |
Allocation concealment? | No | C - Inadequate |
Blinding? All outcomes |
Yes | Single blinding. |