Methods | Between June 1988 and August 1989, 103 patients who gave informed consent to participate in the study underwent cardiopulmonary bypass. Of the initial 103 patients, 71 were excluded from the study. Method of randomisation and allocation concealment was not described | |
Participants | 32 patients undergoing cardiac surgery requiring cardiopulmonary bypass were randomised to one of two groups:
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Interventions |
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Outcomes | Outcomes reported: amount of allogeneic blood transfused, amount of autologous blood transfused, number of patients transfused autologous and/or allogeneic blood, complications, bleeding times, plasma protein variables, post transfusion febrile reactions | |
Notes | Transfusion threshold: the decision to transfuse a patient post-operatively was made by the clinician who was responsible for the patient’s post-operative care, and who was not involved in the study. The clinical criteria used to determine the need for transfusion consisted of the following: systolic BP less than 80mmHg; mean arterial pressure less than 50mmHg; central venous pressure (CVP) less than 5mmHg; pulmonary capillary wedge pressure (PCWP) less than 5mmHg; cardiac index (CI) less than 2.0L/min/m2; evidence of inadequate end-organ perfusion (ie: urine output less than 20ml/hr), or anaemia (Hct less than 25%). Any patient who bled more than 400ml in the first 4 hours post-operatively and who met any of these criteria underwent transfusion | |
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 concealment treatment allocation was unclear. |
Blinding (performance bias and detection bias) All outcomes |
High risk |