Effects of Red Blood Cell Transfusion on Mortality and Morbidity in Patients With Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,005
- 试验地点
- 32
- 主要终点
- Mortality
研究概览
简要总结
Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. The evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in these very sick patients
详细描述
Background Septic patients often receive red blood cell (RBC) transfusions in the intensive care unit. The evidence that RBC transfusion leads to improved outcome is limited and the intervention may be harmful to some of these patients. In contrast, current guidelines recommend restrictive transfusion of RBC for critical ill patients without septic shock. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in patients with septic shock
Design Pragmatic, multicenter, randomised, outcome assessment-blinded trial of patients with septic shock to RBC transfusion at haemoglobin (Hb) transfusion trigger of 7 g/dl (4.4 mM) or 9 g/dl (5.6 mM), stratified by the presence of haematological malignancy and centre.
Inclusion and exclusion criteria:
To increase the validity of the trial inclusion criteria will be broad with few exclusions
Outcome measures The outcome measures will mainly be patient-important but ICU- and hospital length of stay will also be assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patient in the ICU AND
- •Fulfil the criteria for septic shock AND
- •Have haemoglobin of 9.0 g/dl (5.6 mM) or less AND
- •Consent obtainable from patient or proxy or national law allows delayed consent
排除标准
- •Documented wish against transfusion OR
- •Previous serious adverse reaction with blood product OR
- •Acute coronary syndrome OR
- •Life-threatening bleeding OR
- •RBC transfusion during current ICU admission OR
- •Withdrawal from active therapy or brain death OR
- •Lack of informed consent (depending on national law) OR
- •Acute burn injury regardless of degree and burn surface area
结局指标
主要结局
Mortality
时间窗: 90 day
All cause 90 day mortality
次要结局
- Persistent organ failure(Day 28)
- Anaphylactic/allergic reactions(Followed up until ICU discharge; an expected average of one week)
- Haemolytic complications after transfusion of RBC(Followed up until ICU discharge; an expected average of one week)
- Transfusion associated acute lung injury (TRALI)(Followed up until ICU discharge; an expected average of one week)
- Transfusion associated circulatory overload (TACO)(Followed up until ICU discharge; an expected average of one week)
- Ischaemic events(Followed up until ICU discharge; an expected average of one week)
- Days alive without life support(90-days)
- Days alive and out of hospital(90 days)
- Mortality within the whole observation period(One year after randomisation of the last patient)
- Health-related quality of life(1 year)
研究者
Anders Perner
Principle Investigator
Scandinavian Critical Care Trials Group