Safety and effectiveness of a Patient Blood Management Programme in surgical patients – the study design for a multicentre epidemiological non-inferiority trial by the German PBM network

Background Patient blood management (PBM) concepts aim to identify patients with anemia and optimize their treatment including use of preoperative iron substitution, blood-sparing techniques and adequate transfusion practice. PBM concepts thus have great potential to increase patient safety and clinical outcome. Nevertheless, up to now, structured PBM programmes have only been implemented in very few hospitals in Germany and safety data regarding clinical outcome parameters is rare. Methods The German PBM network was founded in January 2014 and joined by 24 hospitals different hospitals of varying sizes and levels of patient care. An evidence-based PBM programme will be applied in these hospitals reforming the care of adult patients undergoing surgery, and data will be monitored prospectively. This PBM programme includes the following three main pillars: (1) preoperative optimization of hemoglobin levels in high-risk patients suffering from anemia, (2) standardization of transfusion practice according to evidence-based guidelines and (3) wide implementation of alternatives to transfusion of allogeneic red blood cell (RBC) concentrates including blood-sparing techniques. Primary endpoints are the following composite endpoints: (1) in-hospital myocardial infarction, (2) stroke, (3) acute renal failure, (4) death of any cause, (5) pneumonia and (6) sepsis until hospital discharge in patients before and after the implementation of the PBM programme. Conclusions This trial will determine whether the implementation of a PBM programme is safe and effective in terms of clinical outcome. Data will be compared to data prior to implementation of PBM in (the same?) 20 Germany hospitals.