Methods | A randomised controlled trial was conducted to evaluate the safety and effectiveness of the collection and re-transfusion of post-operatively shed mediastinal blood in patients undergoing cardiac surgery. Method of randomisation and allocation concealment were not described | |
Participants | 113 consecutive adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass were randomised to one of two groups:
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Interventions |
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Outcomes | Outcomes reported: amount of blood collected by the cell saver, amount of blood retransfused from the cell saver, amount of allogeneic blood transfused, adverse events, myocardial infarction, mortality, post-operative infections, renal function impariment, fluid replacement, blood loss | |
Notes | Transfusion threshold: intra-operative blood replacement was left to the discretion of the staff surgeon and anaesthesiologist. In patients who were unstable haemodynamically and in those patients whom complete revascularisation was not possible the haematocrit was raised to 30% or higher | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method used to generate allocation sequences was not described |
Allocation concealment (selection bias) | Unclear risk | Method used to conceal treatment allocation was unclear. |
Blinding (performance bias and detection bias) All outcomes |
High risk |