Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations.

Several major orthopaedic surgical procedures may result in significant blood loss and the need for allogeneic blood transfusion (ABT). However, overall concerns about adverse effects of ABT have prompted the review of transfusion practice and the search for transfusion alternatives to decrease or avoid the use of ABT. These strategies include the correction of perioperative anaemia, pharmacological and non-pharmacologic measures to reduce blood loss, preoperative autologous blood donation and perioperative red blood cell salvage. We have reviewed the efficacy and safety of these strategies and where appropriate offer evidence-based recommendations on their use in orthopaedic surgery. We also reviewed the European regulations on ABT alternatives. Pharmacological alternatives need to be used with a total adherence to European regulations in their legal and off-label use. The administration and use of pharmacological agents to stimulate erythropoiesis or reduce blood loss needs to be within the context of attempting to use allogenic blood in a rational manner. As for autologous blood, European Directives cover preoperative autologous blood donation, but not its clinical use, and perioperative red blood cell salvage devices, but not the product yielded by them. Therefore, the development of quality standards and good practice guidelines for perioperative red blood cell salvage, as well as its inclusion in the haemovigilance programme, is urgently needed. Finally, it is noteworthy that some recommendations given for ABT alternatives are not supported by a high level of evidence and that the goal of performing major orthopaedic surgical procedures without the use of ABT may be better accomplished by combining several of these techniques within a defined algorithm.