A Feasibility Randomized Trial Comparing Restrictive and Liberal Blood Transfusion Strategies in Patients Requiring Four or More Days in Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups.
研究概览
简要总结
The most effective transfusion practice in critically ill ICU patients is unknown. Currently the data is unclear as to whether a liberal or restrictive transfusion policy is of most benefit to patients in the short and longer term. The aim of this study is to test the hypothesis that liberal use of RBCs (Hb transfusion trigger ≤90g/L; target Hb range 91-110 g/L) to correct anaemia improves clinical outcomes compared with a restrictive transfusion trigger (Hb transfusion trigger ≤70 g/L; target Hb range 71-90 g/L) in anaemic critically ill patients requiring prolonged ICU stay (≥4 days).
Patients will be randomised to one of two transfusion strategies on a 1:1 basis
Group 1 "Restrictive RBC Transfusion group":
Patients will receive single unit RBC transfusions with a transfusion trigger of ≤70 g/L with a target Hb concentration of 71-90 g/L during the intervention period.
Group 2 "Liberal RBC transfusion group":
Patients will receive single unit RBC transfusions with a transfusion trigger of ≤90 g/L with a target of 91-110 g/L during intervention. These patients will all receive a transfusion on the day of randomisation.
Duration of Intervention:
Remainder of ICU stay or 14 days from randomisation, whichever is longer
Follow-Up
Quality of Life, mobility and health service usage questionnaires at 60 and 180 days.
This is a feasibility study that will provide essential data to ensure the success of the full trial. A qualitative study will also be carried out to explore potential reasons for non-recruitment and clinician concerns with the existing protocol. An exploratory biomarker sub-study will test whether a pro-inflammatory signal occurs in the liberally transfused group associated with transfusions.
详细描述
Anaemia is a common complication of critical illness and 40-50% of all patients in intensive care units (ICUs) receive blood transfusions. However, despite the perceived benefits of correcting anaemia, numerous non-randomised cohort studies and a system review suggest associations between blood transfusions and adverse patient outcomes. The only large randomised controlled trial comparing restrictive with liberal transfusion policies in critically ill patients (the "TRICC study") suggested a trend to greater morality at 30 days in the liberal transfusion group. However the TRICC study does not inform clinical practice with regard to how to manage long stay ICU patients. Also, and importantly, the blood product used in the TRICC study contained white blood cells (non-leucodepleted), which are associated with adverse events, whereas blood in the UK now has the white blood cells removed prior to blood storage (leucodepleted). Due to continuing uncertainty many clinicians continue to use higher Hb transfusion triggers in longer-term ICU patients and we confirmed this recently in a survey of 184 ICU clinicians.
This uncertainty is important for patients, clinicians and the blood services. For example, patients who require longer stays in ICU have long recovery times, use significant hospital resource, and suffer symptoms such as fatigue, breathlessness and reduced Health Related Quality of Life (HRQoL) for many months. It is possible that blood transfusions could alleviate some of these problems. In addition, donated blood is in short supply and is increasingly expensive to produce. As 40% of ICU patients receive transfusions, and use 8% of the Scottish blood stocks, a stronger evidence base could optimise the use of this precious resource.
A Cochrane systematic review (co-authored by one of the applicants, BMcL) noted that current evidence was dominated by the TRICC trial, and concluded that the "....effects of conservative transfusion triggers on functional status, morbidity and mortality, particularly in patients with cardiac disease, need to be tested in further large clinical trials"4. Further studies are clearly required to determine the most effective transfusion practice in critically ill ICU patients.
We have completed an extensive programme of work to inform this study. Based on this data we have identified a patient population in whom an RCT will address many areas of clinical uncertainty. We will study longer-term ICU patients (higher illness severity; higher morbidity; worse long-term functional status; low long-term HRQoL; greater illness costs) who are aged ≥55 (high incidence of IHD; less certainty regarding safety with restrictive approach in TRICC trial). The treatment exposure will last longer than the TRICC trial, potentially including post-ICU care, because anaemia recovers slowly.
This study is a feasibility study comparing the effectiveness of a "restrictive" blood transfusion policy in long-stay ICU patients with a more "liberal" transfusion policy to inform the definitive RCT design. It has been designed to answer the following questions
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 (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient remains in the ICU after 96 hours (4 days) or more following ICU admission
- •The patient has required mechanical ventilation via an endotracheal tube or tracheostomy tube for 96 hours or more
- •The patient is expected to require ≥24 hours of further mechanical ventilation at the time of assessment
- •The patient is aged ≥55 years of age
- •The patient has a Hb value of 90g/L or less at the time of assessment
排除标准
- •Patient with active bleeding at the time of screening
- •Patient with traumatic brain injury as presenting diagnosis
- •Patient with intracranial haemorrhage as presenting diagnosis
- •Patient not expected to survive the next 48 hours at the time of assessment.
- •Patient objects to RBC transfusion
- •Patient receiving concurrent treatment with erythropoietin or similar erythropoietic agent
- •Follow up is not feasible
- •Already enrolled in another RCT with similar clinical endpoints
结局指标
主要结局
Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups.
时间窗: 60 days following randomisation
次要结局
- assessment of complication rate in two treatment arms(60 days following randomisation)
- assessment of length of stay in ICU and hospital(60 days following randomisation)
- Long term follow-up to determine survival status and assess mobility, quality of life & use of health services(60 and 180 days following randomisation)