Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients

Conditions
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Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All non- ambulant, surgical, anesthetized patients (≥18 years) General Surgery, Cardiac Surgery, Thoracic Surgery, Trauma Surgery, Vascular Surgery, Urology, Gynecology, Otolaryngology, Neurosurgery, Crania-Maxillofacial Surgery Exclusion Criteria: ambulant and all non-surgical anesthetic procedures Surgery in the field of Dermatology or Ophthalmology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control cohort<br>Standard care before implementation (pre-implementation) | |
| PBM cohort<br>After implementation of PBM program (post-implementation) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient blood management, patients safety