Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Number of PRBCs transfused per VA-ECMO day of support
研究概览
简要总结
This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.
An individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness
详细描述
Peripheral VA-ECMO is the mainstay of mechanical circulatory support in refractory cardiogenic shock. This treatment is associated with a high consumption of packed red blood cells (PRBCs), which can reach 1 to 3 units of PRBCs per day of support. The main reasons for such a high consumption of PRBCs are the very frequent hemorrhagic complications and the prevalence of anemias not directly related to the hemorrhagic episodes. These anemias are frequent during VA-ECMO support owing to hemolysis, hemodilution, previous bleeding episodes, thrombosis, etc.
In order to restore, maintain, or increase oxygen delivery (DO2) to peripheral organs, RGCs are often performed when anemia is observed. Several studies have reported an association between transfusion of these PRBCs with morbidity and mortality in this ECMO setting.
There is no appropriate strategy to reduce PRBC consumption, taking into account other determinants of DO2. In addition, there is currently no validated or consensus hemoglobin threshold to guide transfusion in this specific population. Furthermore, this predefined threshold-based approach may be inappropriate in the setting of VA-ECMO due to differences in DO2 requirements between patients based on their etiology, disease severity, and ECMO modality. In addition, large variations in DO2 can be observed in the same patient and between ECMO settings. Therefore, a more individualized strategy guided by a DO2 surrogate, ScVO2, may be more appropriate in this population. This ScVO2 approach has recently been shown to be associated with reduced PRBCs in two randomized controlled trials in cardiac surgery patients.
The objective of this multicenter randomized controlled trial is to compare two red cell transfusion strategies in patients receiving extracorporeal veno-arterial membrane oxygenation for refractory cardiogenic shock.
An individualized transfusion strategy based on ScVO2 level is compared with a conventional strategy based on a predefined hemoglobin threshold. The primary endpoint is red blood cell consumption, the secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and datamanagement responsible for statistical analysis will be blinded of the patient allocation group until the study completion
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 of 18 and older,
- •supported by peripheral VA-ECMO
- •for cardiogenic shock
- •Life expentency >90 days
- •Central venous line available ScVO2 measurement
排除标准
- •Pregnancy,
- •Lack of health insurance,
- •Opposition to blood transfusion,
- •Known congenital hemoglobin disease or disorder,
- •Metabolic alcaloosis with pH>7.8,
- •Legally incapacitated adults
研究组 & 干预措施
Individulised transfusion strategy group
Patients will recieve red blood cells transfusion in case of a drop of ScVO2 <65% after an assessment for the optimisation of SaO2 normalisation (SaO2>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain
干预措施: Packed Red Blood Cells (PRBCs) (Drug)
Conventionnal transfusion strategy group
Transfusion will be performed in case of a hemoglobin drop <9 g/dL
干预措施: Packed Red Blood Cells (PRBCs) (Drug)
结局指标
主要结局
Number of PRBCs transfused per VA-ECMO day of support
时间窗: From randomisation until VA-ECMO weanning assessed up to 28 days
Total number of PRBCs transfused during support adjusted for VA- ECMO duration
次要结局
- Hospital lenght of stay(28 days from cannulation)
- Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients(From randomisation until VA-ECMO weanning assessed up to 28 days)
- Total number of PRBCs transfused during the 28-day following cannulation(From randomisation until 28 days)
- Changes in hemoglobin levels during VA-ECMO support(From randomisation until VA-ECMO weanning assessed up to 28 days)
- Changes in ScVO2 levels during VA-ECMO support(From randomisation until VA-ECMO weanning assessed up to 28 days)
- Mortality under ECMO support(From randomisation until VA-ECMO weanning assessed up to 28 days)
- Changes in vosoactive index score levels during VA-ECMO support(From randomisation until VA-ECMO weanning assessed up to 28 days)
- HLA immuno-sensitisation(28 and 90 days from cannulation)
- Proportion of patient with Transfusion related immunologic ( non HLA-related) complications(From randomisation until 28 days)
- Proportion of patients with nex onset of sepsis(From randomisation until 28 days)
- 90-day Mortality(90 days from cannulation)
- Proportion of patient that received a renal replacement therapy and its duration(28 days from cannulation)
- Duration of vasoactive support(28 days from cannulation)
- ECMO removal modalities(From randomisation until VA-ECMO weanning assessed up to 28 days)
- Duration of mechanical ventilation(28 days from cannulation)
- Proportion of patients with a new onset of acute kidney injury(From randomisation until 28 days)
- Proportion of patients with liver failure(From randomisation until 28 days)
- Ischemic stroke(From randomisation until 28 days)
- Myocardial infarction(From randomisation until 28 days)
- Pulmonary oedema(From randomisation until 28 days)
- Anaphylactic complications(From randomisation until 28 days)
- Bowel Ischemia(From randomisation until 28 days)
- Cost effectiveness analysis(28 days, 90 days and 5 years from randomisation)