Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110,000
- 试验地点
- 4
- 主要终点
- Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome
研究概览
简要总结
This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •ambulant and all non-surgical anesthetic procedures
- •Surgery in the field of Dermatology or Ophthalmology
结局指标
主要结局
Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital
次要结局
- Total hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- 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 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)
研究者
Professor Kai Zacharowski, M.D., Ph.D., FRCA
Prof. Dr. Dr. Kai Zacharowski
Johann Wolfgang Goethe University Hospital