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| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
| University Hospital, Bonn | OTHER |
| University Hospital Muenster | OTHER |
| Vifor Pharma |
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This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.
A PBM program will be implemented stepwise in four University Hospitals, with the intention to optimize preoperative hemoglobin concentration of patients and to standardize transfusion practice within hemotherapy. The PBM program includes 1) an algorithm with the aim to correct preoperative anemia in elective surgery, 2) a strict indication for the transfusion of red blood cells defined by the "Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives" for all surgical patients, and 3) a perioperative checklist for different blood-sparing techniques (e.g. cell-saver, normothermia, reduced blood samples, point-of-care diagnostics for bedside coagulation management).
Primary endpoint: Safety of the use of PBM program will be determined by comparability of the composite outcome (in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital) between patients treated after implementation and patients treated before implementation (control cohort) of the PBM program.
The primary composite endpoint defined as described above will be registered electronically by analysis of Diagnosis Related Groups (DRG) codes. The frequency of these events will be compared between PBM and control cohort stratified by center with a one-sided Mantel-Haenszel test in a non-inferiority setting with significance level of α=2.5% and a non-inferiority margin of 1% for the incidence of the composite endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cohort | Standard care before implementation (pre-implementation) | ||
| PBM cohort | After implementation of PBM program (post-implementation) |
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| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome | Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay on the intensive care unit | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | |
| Total hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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all surgical patients over a period of 24 months at 4 hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Kai Zacharowski, MD, PhD, FRCA | Goethe University | Study Chair |
| Patrick Meybohm, MD | Goethe University | Principal Investigator |
| Erhard Seifried, MD | German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, Frankfurt | Principal Investigator |
| Eva Herrmann | Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bonn | Bonn | Germany | ||||
| University Hospital Frankfurt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29944518 | Derived | Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583. | |
| 27163948 |
| Label | URL |
|---|---|
| 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 | View source |
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| INDUSTRY |
| B. Braun Melsungen AG | INDUSTRY |
| CSL Behring | INDUSTRY |
| Fresenius Kabi | INDUSTRY |
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| Total number of red blood cell transfusions during hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Consumption of coagulation factors | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Frankfurt |
| Germany |
| University Hospital Schleswig-Holstein | Kiel | Germany |
| University Hospital Muenster | Münster | Germany |
| Meybohm P, Herrmann E, Steinbicker AU, Wittmann M, Gruenewald M, Fischer D, Baumgarten G, Renner J, Van Aken HK, Weber CF, Mueller MM, Geisen C, Rey J, Bon D, Hintereder G, Choorapoikayil S, Oldenburg J, Brockmann C, Geissler RG, Seifried E, Zacharowski K; PBM-study Collaborators. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design. Ann Surg. 2016 Aug;264(2):203-11. doi: 10.1097/SLA.0000000000001747. |
| 25927460 | Derived | Meybohm P, Fischer DP, Geisen C, Muller MM, Weber CF, Herrmann E, Steffen B, Seifried E, Zacharowski K; German PBM Study Core Group. 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. BMC Health Serv Res. 2014 Nov 19;14:576. doi: 10.1186/s12913-014-0576-3. |