Abstract

Transfusion of autologous whole blood is one available method to reduce the need for allogenic blood transfusion. The objective of this study was to investigate the safety of transfusion of intra-operative autologous whole blood by monitoring plasma concentration of laboratory variables and adverse events after transfusion with the Sangvia(®) system. The clinical trial was designed as an open, prospective, multi-centre study, and a total of 20 patients undergoing primary hip arthroplasty were included. Systemic blood samples were taken and analysed preoperatively, at transfusion start and end and at 3, 6, 24 and 48 h after the transfusion. Elevated values of complement activation and pro-inflammatory cytokines were seen in the intra-operatively collected blood but the impact on systemic levels were limited with low peak levels, systemic elevations before transfusion and normalization during the study period. Elevated levels of free haemoglobin and potassium were also detected in the intra-operatively collected blood, but systemic values were within reference values after the transfusion. No clinically relevant adverse event occurred during the study. Inflammatory mediators and plasma haemoglobin were increased in intra-operatively salvaged and filtered blood compared to circulatory levels. Intra-operative retransfusion of autologous whole blood caused a transient systemic increase that normalized in the early postoperative period. There were no significant adverse events reported in the study. These data suggest that the Sangvia(®) system can be used for intra-operative collection and retransfusion of salvaged blood.

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