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临床试验/NCT02147795
NCT02147795招募中不适用

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

Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 1,000,000 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000,000
试验地点
2
主要终点
Composite Outcome for and after PBM program

研究概览

简要总结

  • 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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • all surgeries with a general or local anaesthetic
  • minimum hospital stay of 24 h
  • ≥ 18 years

排除标准

  • < 18 years
  • ophthalmologic or dermatologic or outpatient surgery
  • all non-surgical anesthetic procedures

结局指标

主要结局

Composite Outcome for and after PBM program

时间窗: 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

次要结局

  • haemotherapy(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
  • Length of stay(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Kai Zacharowski, M.D., Ph.D., FRCA

Professor Kai Zacharowski, M.D., Ph.D., FRCA

Johann Wolfgang Goethe University Hospital

研究点 (2)

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