A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,994
- 试验地点
- 61
- 主要终点
- Mortality at Day 90
研究概览
简要总结
In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.
详细描述
Inclusion criteria
•Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.
Exclusion criteria
- Age younger than 18
- Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
- Diagnosis of transplantation or hematologic diseases
- Pregnancy
- Cardiac surgery during the present hospital admission
- Expected to die imminently (<24hrs)
- The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
- Known objection to the administration of human blood products
- Participation in a competing study
Primary outcome- 90 day mortality
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two staff not involved in the direct care of each patient checked the red-cell units, and concealed the collection and expiry dates from clinical staff using a bag with opaque panels (Australia, Ireland and Saudi Arabia), or an obscuring sticker (NZ and Finland).
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
- •Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.
排除标准
- •Age younger than 18
- •Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
- •Diagnosis of transplantation or hematologic diseases
- •Pregnancy
- •Cardiac surgery during the present hospital admission
- •Expected to die imminently (<24hrs)
- •The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
- •Known objection to the administration of human blood products
- •Participation in a competing study (see below)
结局指标
主要结局
Mortality at Day 90
时间窗: 90 Day
Mortality at Day 90
次要结局
- Mortality at Day 28(28 day)
- Persistent Organ Dysfunction Combined With Death Measured at Day 28(day 28)
- Days Alive and Free of Mechanical Ventilation(day 28)
- Length of Stay in ICU and in Hospital Post Randomisation (Days)(Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3))
- Day Alive and Free of Renal Replacement Therapy.(day 28)
- Blood Stream Infection in ICU (Post Randomisation)(While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4))
- Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU(While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4))
- EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation(Day 180)
研究者
David James Cooper
Professor
Australian and New Zealand Intensive Care Research Centre