The German Patient Blood Management Network
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|ClinicalTrials.gov Identifier: NCT02147795|
Recruitment Status : Recruiting
First Posted : May 28, 2014
Last Update Posted : March 2, 2018
- This epidemiological 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
- Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program.
- Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay.
- The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.
|Condition or disease|
|Clinical Safety of a PBM Program|
Background: The transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. However, transfusion practice currently varies significantly between hospitals and even between physicians and Patient Blood Management programs have not been implemented nationwide in Germany yet. Patient Blood Management (PBM) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. A rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. The purpose of the German PBM network is to evaluate the safety of a standardized, evidence-based Patient Blood management concept.
Study Design and Methods: This epidemiological study is a follow-up of a study that is already being carried out in four German university hospitals. This new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. A patient-centred, evidence-based Patient Blood Management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. This PBM program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic RBC concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).
|Study Type :||Observational|
|Estimated Enrollment :||200000 participants|
|Official Title:||Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Standard care before implementation (pre-implementation)
After implementation of PBM program (post-implementation)
- Composite Outcome for and after PBM program [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program
- Length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]length of stay on the intensive care unit, total hospital stay
- haemotherapy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and any other haemotherapy (including use of cell salvage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147795
|Contact: Kai D Zacharowski, Prof, MD, PhD||0049 69 6301 ext 5998||Direktion.Anaesthesie@kgu.de|
|Contact: Patrick Meybohm, M.D||0049 6906301 ext email@example.com|
|Johann Wolfgang Goethe University Hospitals||Recruiting|
|Frankfurt, Germany, 60590|
|Contact: Dania P Fischer, M.D +49 (0) 157 76400784 firstname.lastname@example.org|