Impact of Transfusions and Patient Blood Management on Morbidity and Mortality in Severe Anemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Number of dead participants at the end of hospitalization (inhospital mortality)
研究概览
简要总结
The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question[s] it aims to answer are:
- Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions?
- Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient 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 hematopoesis and homeostasis.
Objective:
The objectives of the present study is to investigate the effects of 2 different management strategies of severe anemia, namely PBM exclusively or PBM with transfusion therapy, and compare them to standard transfusion therapy as regards inhospital mortality and morbidity.
Hypothesis: It is hypothesized that severely anemic participants who received a combination of PBM and restrictive transfusion regime would have a lower mortality and less complications than participants receiving a liberal transfusion therapy without PBM, while participants not being transfused at all will have increased mortality and morbidity.
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
- •nadir hemoglobin < 8 g/dL
排除标准
- •treatment in a non-comparable specialty
- •transfer from hospital in the first 6 h after arrival
- •requesting PBM / transfusion-free therapy but not offered
结局指标
主要结局
Number of dead participants at the end of hospitalization (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
Death at discharge from hospital
次要结局
- Number of participants with a documented 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)
- Number of participants suffering 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)
- Number of participants with a documented 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)
- Number of participants readmitted to the studied 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 100 months)
- Number of participants with documented 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)
- Number of participants with surgical wound 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)
- Number of days spent in hospital (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 100 months)
- Number of participants treated in an intensive care ward(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 participants receiving an allogeneic transfusion(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)
研究者
Petra Seeber
Principal Investigator
Helios Klinik Gotha/Ohrdruf