Red Blood Cell Transfusion to Optimize Extubation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Rate of reintubation or death following planned extubation.
研究概览
简要总结
In comparison with a liberal transfusion strategy (high haemoglobin threshold), a restrictive transfusion strategy leads to around 50% decrease in the total number of transfused red blood cells (RBC) units and 30% to 40% fewer transfused patients, without any difference in mortality. However, the optimal transfusion strategy where RBC benefits outweigh the risk of both anaemia and RBC transfusion), that depends on patients comorbidities and conditions, is likely to change over the stay in intensive care. Ventilator liberation is one of those clinical states with an increase in oxygen consumption. Low haemoglobin at the time of extubation has been identified to be associated with an increased risk of reintubation. The rate of reintubation has decreased over the last decades thanks to the development of post extubation strategies; however, reintubation remains a dreaded event associated with an increased morbidity and mortality.
The hypothesis is that a single unit of RBC transfused at the time of extubation would increase the success of extubation defined by survival without reintubation at day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age ≥ 18 years
- •Duration of invasive mechanical ventilation prior to extubation ≥ 24h
- •Planned extubation after weaning trial success
- •Patients at high risk of reintubation having at least one of the following criteria: older than 65 years, underlying chronic cardiac disease (including: left ventricular ejection fraction ≤ 45%, documented ischemic cardiopathy, chronic supraventricular arrhythmia, history of cardiogenic pulmonary edema) or lung disease (including documented or suspected: chronic obstructive pulmonary disease, obesity-hypoventilation syndrome, or restrictive pulmonary disease)
- •Haemoglobin level between 7.5 and 9.5 g/dl in the previous 48 hours (with no active bleeding and no transfusion in the interval)
- •Express informed consent (oral) from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy relatives to give consent
- •Affiliated to social security
排除标准
- •Acute coronary syndrome with ST elevation in the previous 4 weeks
- •Peripheral neuromuscular disease as reason for intubation (underlying myopathy or myasthenia gravis)
- •Known objection to the administration of human blood products
- •Active bleeding
- •Inclusion in another trial investigating RBC transfusion and/or erythropoietin/ and/or post extubation strategies
- •Do-not-reintubate order at time of extubation
- •Vulnerable persons, under the protection of justice
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons under legal protection (guardianship, curatorship)
- •Pregnant or breast-feeding woman
研究组 & 干预措施
Expérimental group
Patient will systematically receive a single unit of crossed match leukoreduced RBC within the 4 hours of randomization
干预措施: Transfusion of a single unit of RBC and standard of care (Other)
Control group
Patient will receive standard of care alone
结局指标
主要结局
Rate of reintubation or death following planned extubation.
时间窗: up to day-7
次要结局
- Reintubation(48 hours, 72 hours and up to ICU discharge)
- Acute respiratory failure following extubation(Up to day-7)
- Cardiogenic pulmonary oedema following extubation(up to day-7)
- Number of ventilatory support-free days following extubation(up to day-14)
- Length of stay in ICU(up to day-60)
- Length of hospital stay(up to day-60)
- Mortality in ICU(at day 28 and at day 60)
- Mortality in hospital,(at day 28 and at day 60)
- Number of RBC transfused in ICU after randomization(up to day-60)
- Number of RBC transfused in hospital after randomization(up to day 60)
- Quality of life(at day-60)
- Hospital-acquired bacteraemia in ICU(up to day-60)
- Severe post transfusion allergic reaction(up to day-60)
- Quality of life questionary(at day-60)