Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,456
- 试验地点
- 18
- 主要终点
- Occurrence of a composite endpoint
研究概览
简要总结
In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.
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
- None (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered
- •Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery
排除标准
- •preoperative Hb level ≤ 9 g/dl
- •chronic kidney disease requiring dialysis
- •suspected lack of compliance with follow-up procedures
- •participation in other interventional trials
- •expected death within 3 months
- •inability to provide informed consent with absence of a legally authorised representative/ legal guardian
- •temporary inability to provide informed consent
- •previous participation in our trial
- •patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses)
- •preoperative autologous blood donation.
研究组 & 干预措施
Liberal
Liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)).
干预措施: red blood cell transfusion trigger (Drug)
Restrictive
Restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l).
干预措施: red blood cell transfusion trigger (Drug)
结局指标
主要结局
Occurrence of a composite endpoint
时间窗: 90 days
Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level ≥ 3 times within a time window of 7 days or initiation of renal replacement therapy. V. Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography). VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery.
Occurrence of a composite outcome
时间窗: 90 days
Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level ≥ 3 times within a time window of 7 days or initiation of renal replacement therapy. V. Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography). VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery.
次要结局
- Number of red blood cell units transfused(hospital discharge (an anticipated average of 10 days))
- functional status (Barthel index)(90 days)
- Health-related quality of life(90 days)
- Time to infection(90 days)
- Time to re-hospitalisation(90 days)
- Occurrence of any individual component of the composite(1 year)
- Proportion of patients receiving red blood cell transfusion(hospital discharge (an anticipated average of 10 days))
- Total length of stay in the intensive care unit(hospital discharge (an anticipated average of 10 days))
- Number of participants with acute kidney injury stage I-II(hospital discharge (an anticipated average of 10 days))
- Total length of stay in hospital(hospital discharge (an anticipated average of 10 days))
研究者
Dr. Patrick Meybohm, M.D.
Prof. Dr. Patrick Meybohm
Wuerzburg University Hospital