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.
BACKGROUND
Preoperative 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
This 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.


CONCLUSIONS
This 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).
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.
Patrick
P
Meybohm
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. dania.fischer@kgu.de.
Dania Patricia
DP
Fischer
German Red Cross Blood Transfusion Service Baden-Wuerttemberg - Hessen, Institute of Transfusion Medicine and Immunohematology, Sandhofstrasse 1, Frankfurt am Main, Germany. c.geisen@blutspende.de.
Christof
C
Geisen
German Red Cross Blood Transfusion Service Baden-Wuerttemberg - Hessen, Institute of Transfusion Medicine and Immunohematology, Sandhofstrasse 1, Frankfurt am Main, Germany. m.mueller@blutspende.de.
Markus Matthias
MM
Müller
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. Christian.weber@kgu.de.
Christian Friedrich
CF
Weber
Institute of Biostatistics and Mathematical Modelling, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. herrmann@med.uni-frankfurt.de.
Eva
E
Herrmann
Department of Haematooncology, University Hospital Frankfurt, Frankfurt am Main, Germany. bjoern.steffen@kgu.de.
Björn
B
Steffen
German Red Cross Blood Transfusion Service Baden-Wuerttemberg - Hessen, Institute of Transfusion Medicine and Immunohematology, Sandhofstrasse 1, Frankfurt am Main, Germany. e.seifried@blutspende.de.
Erhard
E
Seifried
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. kai.zacharowski@kgu.de.
Kai
K
Zacharowski
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000628:therapy*; D001771:Blood Banks / Q000592:standards*; D058731:Blood Safety / Q000592:standards*; D001803:Blood Transfusion / Q000592:standards*; D005260:Female; D005858:Germany; D006470:Hemorrhage / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015397:Program Evaluation; D011446:Prospective Studies