Methods | In 2003, patients ≥18 years of age who were scheduled for a primary or revision total hip replacement or total knee replacement at the Leiden University Medical Centre were included in this randomised controlled trial. All patients were of American Society of Anaesthesiologists (ASA) 2 or 3 category. A randomisation list was generated by a statistical software package. Sealed envelopes were made which contained the randomisation group. Pre-operatively, the patient was allocated to one of the groups by opening a sealed envelope | |
Participants | 70 patients undergoing a primary or revision total hip replacement or total knee replacement were randomised to one of three groups:
|
|
Interventions |
|
|
Outcomes | Outcomes reported: number of patients transfused allogeneic blood, amount of allogeneic blood transfused, volume of blood re-transfused from the cell saver, blood loss, hospital length of stay, adverse events | |
Notes | Transfusion threshold: during the study, a restrictive transfusion trigger according to the Dutch guidelines was used (CBO consensus guidelines, 2004) | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Method used to generate allocation sequences was adequate. |
Allocation concealment (selection bias) | High risk | Method used to conceal treatment allocation was inadequate. |
Blinding (performance bias and detection bias) All outcomes |
High risk |