Methods | Randomisation was provided by a series of computer-generated random numbers. All study medication was dispensed by the investigator or hospital pharmacy | |
Participants | 83 patients undergoing valvular heart operations with or without concomittant coronary artery bypass surgery were randomised to one of two groups
|
|
Interventions |
NB: Both groups were exposed to pre-operative autologous blood donation (PAD) and postoperative epsilon aminocaproic acid (EACA) |
|
Outcomes | Number of patients transfused allogeneic blood (n) Amount of allogeneic and autologus blood transfused (units) Fresh frozen plasma (FFP) transfused (n/units) Platelets transfused (n/units) Blood loss (mls) Mortality (n) Myocardial infarction (n) Re-operation for bleeding (n) Bowel infarction (n) Brain stem infarction (n) Femoral artery embolism (n) Cardiac arrest (n) Retinal artery embolism (n) |
|
Notes | Quality assessment score (Schulz criteria): 4/7 Transfusion protocol not specified. |
|
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Randomisation was provided by a series of computer-generated random numbers |
Allocation concealment? | Unclear | B - Unclear. |
Blinding? All outcomes |
Yes | Double blind. |