Methods |
A prospective, randomised study was performed in a New Delhi tertiary care hospital involving consecutive patients undergoing elective cardiac valve surgery using cardiopulmonary bypass. Method of randomisation and allocation concealment were not described |
Participants |
150 consecutive patients undergoing elective valve surgery using cardiopulmonary bypass were randomly allocated to one of three groups:
Group 1 (Autotransfusion + ANH group): n=50; M//F=35//15; mean (sd) age = 29.1 (11.8) years
Group 2 (ANH group): n=50; M//F=25//25; mean (sd) age = 28.1 (9.2) years
Group 3 (Control group): n=50; M//F=15//35; mean (sd) age = 26.1 (9.3) years
ANH = acute normovolaemic haemodilution. |
Interventions |
Group 1: Autotransfusion + ANH group received autologous fresh blood donated before bypass, and both cell saver and membrane oxygenator were used. Autologous blood was removed by a central venous catheter after induction of anaesthesia and collected in citrate phosphate preservative at room temperature for subsequent transfusion. Blood volume was maintained with a simultaneous infusion of Ringer’s lactate solution. A Dideco, Shiley cell saver system was used to collect all blood at the operation site. This system heparinises, washes, and centrifuges the blood to produce a red cell concentrate for transfusion. At the conclusion of CPB, all the blood remaining in the oxygenator was also processed by the cell saver in preparation for subsequent transfusion. A “Maxima” membrane oxygenator was used for this group.
Group 2: ANH group were reinfused with autologous blood only. Blood was withdrawn as in Group 1 patients and was stored for subsequent transfusion.
Group 3: Control group underwent routine management, using a Bentley bubble oxygenator without specific blood conservation techniques.
NB: In Groups 2 and 3, the blood remaining in the oxygenator at the termination of CPB was returned to the patient before decannulation, or collected in a bag for immediate use to provide optimum filling pressures and haemodynamic stability in the post-bypass period |
Outcomes |
Outcomes reported: amount of allogeneic blood transfused, number of patients transfused allogeneic blood, adverse events, re-exploration for bleeding, blood loss, Hct levels |
Notes |
Transfusion threshold: bank blood (whole blood) was used in all groups if the haematocrit was less than 25% |
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 |
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