• Bmc Health Serv Res · Nov 2014

    Multicenter Study Comparative Study

    Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial.

    • Patrick Meybohm, Dania Patricia Fischer, Christof Geisen, Markus Matthias Müller, Christian Friedrich Weber, Eva Herrmann, Björn Steffen, Erhard Seifried, Kai Zacharowski, and German PBM Study Core Group.
    • Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. Patrick.meybohm@kgu.de.
    • Bmc Health Serv Res. 2014 Nov 19; 14: 576.

    BackgroundPreoperative and hospital-acquired anaemia is common among surgical patients. It is associated with an increased risk of morbidity and mortality and a strong risk factor for allogeneic blood transfusions with their own inherent risks. Patient Blood Management (PBM) concepts aim to increase and preserve autologous erythrocyte volume and to optimise haemotherapy. They thus have great potential to benefit patients.Methods/DesignThis prospective, multi-centre clinical trial tests the hypothesis that PBM programs are safe and effective in the care of adult surgical patients. Primary outcome is a composite endpoint of adverse events and in-hospital mortality.DiscussionThis trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort. This trial is registered at www.clinicaltrials.gov (NCT01820949).

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