Methods |
Prospective, randomised controlled trial was conducted to determine the effectiveness of a post‐operative autologous blood re‐infusion system as an alternative to allogeneic, banked blood in patients undergoing unilateral total knee replacement between January 2002 to November 2004. |
Participants |
60 patients undergoing unilateral total knee replacement were randomly allocated to one of two groups:
|
Interventions |
Group 1: Autotransfusion group (Gish Orthofuser system) had their shed blood collected and re‐infused within 6 hours after the collection was initiated. Allogeneic blood transfused was supplied post‐operatively when required. No banked blood was given intra‐operatively.
Group 2: Control group had a standard wound drainage system. Allogeneic blood transfused was supplied post‐operatively when required. One unit of banked blood was given intra‐operatively.
|
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, Hb & Hct levels. |
Notes |
Transfusion threshold: the criteria for allogeneic blood transfusion post‐operatively were the values of haemoglobin (lower than 9.0g/dL) in correlation with the clinical signs of the patient. |
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 not described. |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
|