PRospective Multicenter Observational Study on Transfusion Practice in Vv-ECMO Patients: The PROTECMO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 656
- 试验地点
- 1
- 主要终点
- Descriptive data of Fibrinogen administration in patients receiving VV-ECMO
研究概览
简要总结
Background: Over the past decade, the use of extracorporeal membrane oxygenation (ECMO) for respiratory support in adults has increased. Several trials have highlighted how red blood cells transfusion can cause several negative effects and, currently, a restrictive transfusion trigger in critically ill patients is widely accepted.
The optimal management of anticoagulation targets and transfusion practice in veno-venous-ECMO (VV-ECMO) patients is still under debate. Traditionally, the threshold for transfusions of packed red blood cells (PRBC) in ECMO is aimed at keeping hemoglobin (Hb) values in the normal range (12-14 g/dL), but some case series have shown how the Hb target can be lower, and with comparable clinical outcomes.
While there are extensive reviews on predicted ECMO survival, and management (even with many debated issues), there is a significant knowledge gap in understanding the benefits and risks of transfusions during VV-ECMO Methods/Design: Prospective observational multicenter study. The principal aim is to describe current effective blood product usage, during VV-ECMO. The secondary aim is to describe in a large cohort of ECMO patients the current anticoagulation strategy and bleeding episodes occurrence.
The study will be conducted at a multicenter level including in each center all consecutive adult vv-ECMO patients during one year up. The data collection will include pre-ECMO characteristics, transfusion strategies and blood test results during the first twenty-eight days after ECMO cannulation or until the end of ECMO support if the length is shorter, and clinical outcomes up to the end of ICU stay.
The descriptive variable end points for the primary aim will be the daily and the total amount of PRBC and other blood products (Plasma, Platelets, Fibrinogen, Antithrombin III).
The descriptive variable end points for the secondary aim will be the type and dose of anticoagulation, and episodes of bleeding according to site and severity.
Expected Results: A collaborative combination of ECMO centers will evaluate prospective data of transfusion practices during ECMO. The investigators would be able to describe the currently strategy for administration of blood products, anticoagulation and the effective incidence of bleeding episodes worldwide.
详细描述
Background Over the past decade, the use of extracorporeal Membrane Oxygnation (ECMO) for respiratory support in adults has vastly increased. Veno-venous ECMO (VV-ECMO) can be initiated in case of Acute Respiratory Distress Syndrome (ARDS) as salvage therapy for patients with profound gas exchange abnormalities despite protective lung ventilation and other rescue therapies. Many aspects of ECMO management are still under debate despite the increasing number of cases. Among these debated topics there is certainly the optimal management of transfusion practice.
Several trials have recognized how red blood cells transfusion can cause several negative effects, including transfusion related immune reactions, the potential transmission of diseases, the development of transfusion-related complications (such as transfusion-related acute lung injury - TRALI - or transfusion-associated circulatory overload - TACO) and immunosuppression. On the other hand, anemia can also cause a potential increase in morbidity and mortality in critically ill patients, and in ECMO is an even greater critical issue in reducing delivery of oxygen (DO2).
Moreover, despite improvement in technology and care, complications related to ECMO are still high, and frequently involve an imbalance in the coagulation status due to anticoagulant use in the presence of coagulopathy. Consequently, the risk of thrombosis (presumably microthrombosis) and hemorrhage remain to be high. In the case of ongoing bleeding, transfusion of Packed Red Blood Cell (PRBC) is required to support desired haemoglobin levels.
Traditionally, the threshold for PRBC transfusions in ECMO is aimed to maintain hemoglobin (Hb) values in the normal range (12-14 g/dL). Despite this, there is considerable uncertainty regarding the optimal haemoglobin threshold for the use of PRBC transfusions in anemic patients during ECMO support.
Prompted by the general reappraisal of PRBC transfusion use, some case series using lower target for Hb during vv-ECMO support have been published. However, such protocols do not use/suggest a definitive trigger/target of Hb.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Descriptive data of Fibrinogen administration in patients receiving VV-ECMO
时间窗: Day 28 after ECMO start
Fibrinogen, amount
Descriptive data of Antithrombin III administration in patients receiving VV-ECMO
时间窗: Day 28 after ECMO start
Antithrombin III, amount
Descriptive data of Platelets transfusion in patients receiving VV-ECMO
时间窗: Day 28 after ECMO start
Platelets, amount
Descriptive data of Plasma transfusion in patients receiving VV-ECMO
时间窗: Day 28 after ECMO start
Plasma, amount
Descriptive data of PRBC transfusion in patients receiving VV-ECMO
时间窗: Day 28 after ECMO start
Packed Red Blood Cells Transfused, amount
次要结局
- Descriptive data of anticoagulation practices in patients receiving VV-ECMO(daily for 28 days)
- Descriptive data of bleeding episodes in patients receiving VV-ECMO(daily for 28 days)
- Correlate the amount of transfusions to clinical outcomes(Day 28 after ECMO start)