Impact of Transfusions and Patient Blood Management on Outcomes in Patients Undergoing Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25,979
- 试验地点
- 1
- 主要终点
- Inhospital Mortality
研究概览
简要总结
The goal of this observational study is to compare patients who underwent major surgery and who were eligible to receive different management of their red blood count, namely, allogeneic transfusions with or without patient blood management, or blood management alone. Its main questions it aims to answer are:
Which group of patients dies more frequently: Patients who receive patient blood management only, patients who receive patient blood management and transfusions where indicated, or patients who are eligible to receive transfusions only.
Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patients blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both.
详细描述
Background:
There seems to be a clear relationship between hemoglobin level and inhospital morbidity and mortality. To mitigate negative effects of lower hemoglobin levels, that is, anemia, transfusions are given when the hemoglobin level of the patient reaches a point deemed detrimental by the treating health care personnel. Patient Blood Management (PBM) adds to the armamentarium of anemia therapy, starting typically well before transfusions are given, and sometimes beyond this point. PBM utilizes medical strategies to enhance the patients own red cell mass and to alleviate the ill effects of disease and bleeding on hematopoiesis and hemostasis.
Objective:
The objectives of this study is to investigate the effects of different blood management strategies in patients undergoing major surgery, namely PBM exclusively or PBM with transfusion therapy combined, and compare them to standard transfusion therapy as regards inhospital mortality and morbidity.
Hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •undergoing major surgery
排除标准
- •treatment in a non-comparable specialty
- •transfer from admitting hospital within 6 h after arrival
- •requesting PBM/ transfusion-free therapy but not offered
研究组 & 干预措施
Study group 1: PBM only
Participants in study group 1 receive full PBM while they opted not to receive transfusions.
干预措施: Patient Blood Management (Other)
Study group 2: PBM with transfusions
Participants in study group 2 receive partial PBM while they opted to receive transfusions. Transfusions are given by physicians encouraged to use a restrictive transfusion strategy. PBM is delivered to participants at a convenient time, resorting to a set of standard PBM measures rather than individualized care.
干预措施: Allogeneic transfusion (Biological)
Study group 2: PBM with transfusions
Participants in study group 2 receive partial PBM while they opted to receive transfusions. Transfusions are given by physicians encouraged to use a restrictive transfusion strategy. PBM is delivered to participants at a convenient time, resorting to a set of standard PBM measures rather than individualized care.
干预措施: Patient Blood Management (Other)
Control group: Transfusions only
The control group is treated in an environment where PBM is not implemented and transfusion is the standard therapy for anemia, major bleeding, thrombopenia and coagulopathy beyond the transfusion trigger.
干预措施: Allogeneic transfusion (Biological)
结局指标
主要结局
Inhospital Mortality
时间窗: From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months
Number of dead participants at the end of hospitalization (inhospital mortality)
次要结局
- Acute myocardial infarction(From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months)
- Respiratory complications(From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months)
- Renal injury(From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months)
- Length of stay in hospital(From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 1000 months)
- Transfusion reaction(From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months)
- Need of Intensive Care Unit treatment(From date of admission to hospital until the date of discharge from hospital or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months)
- Local surgical complications(From date of admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed for the whole hospitalization period, assessed up to 100 months)
- Readmission(From date of admission to hospital until 30 days thereafter)
研究者
Petra Seeber
Principal Investigator
Helios Klinik Gotha/Ohrdruf