Incidence of Bleeding, Thrombosis and Transfusion Requirements in ICU Patients With COVID-19 Supported With Veno-venous Extracorporeal Membrane Oxygenation: a Single-center Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bleeding events
研究概览
简要总结
The investigators aim to assess the risk of bleeding and thrombo-embolic complications as well as benefit and harm of blood product transfusion and anticoagulation therapy in adult ICU patients with COVID-19 supported with V-V ECMO
详细描述
During the SARS-CoV-2 (COVID-19) pandemic millions of people were affected worldwide, some only experiencing minor symptoms whilst some developed acute respiratory distress syndrome (ARDS) requiring admission to the intensive care unit (ICU). ARDS is a life-threatening condition with mortality ranging from 35-48 %. Gas exchange can be severely impaired and, in some cases, conventional mechanical ventilation and adjunct therapies cannot accomplish adequate oxygenation. Veno-venous extracorporeal membrane oxygenation (V-V ECMO) is recommended as a rescue-support for refractory hypoxemia in ARDS also following COVID-19 infection and has been utilised widely. However, optimal management is difficult with prolonged ECMO duration in ARDS patients with COVID-19 and reported survival rates vary considerably 34-66
%. Complications include severe bleeding requiring more red cell transfusions and thrombotic complications, which are common despite increased risk of bleeding. Both bleeding and thrombosis are associated with increased mortality and balancing the opposing risks is challenging in daily management. On one hand, patients are routinely exposed to anticoagulant therapy (e.g. systemic heparin for the ECMO circuit operation), but on the other hand, patients are commonly exposed to blood product transfusions. The timing, monitoring, efficacy and safety of both blood product transfusion and anticoagulant therapy remains poorly understood. The investigators therefore aim to assess the risk of bleeding and thrombo-embolic complications as well as benefit and harm of blood product transfusion and anticoagulation therapy in adult ICU patients with COVID-19 supported with V-V ECMO.
Objectives
- To assess the incidence, site and risks of bleeding and thrombo-embolic events in ICU patients with COVID-19 supported with V-V ECMO.
- To assess the quantity of transfused blood products.
- To assess the clinical practice of anticoagulant therapy in this cohort.
- To assess the incidence of transfusions-related serious adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polymerase chain reaction (PCR) verified COVID-19 infection
- •Supported with V-V ECMO in this center
排除标准
- 未提供
研究组 & 干预措施
Patients with COVID-19 induced ARDS supported with VV ECMO in eastern Denmark
a single-center retrospective cohort study of all adult ICU patients with COVID-19 infection supported with veno-venous extracorporeal membrane oxygenation admitted to the cardio-thoracic intensive care unit at Copenhagen University Hospital, Rigshospitalet.
结局指标
主要结局
Bleeding events
时间窗: 90 days
A bleeding event is defined as any event requiring at least 3 units of red blood cells within 24 hours or transfusion with 3 or more units of either fresh frozen plasma, platelet concentrates or red blood cells within 24 hours, any intracranial bleeding or bleeding requiring invasive/surgical interventions
次要结局
- Thrombo-embolic events(90 days)
- Use of blood products transfusion in the ICU(90 days)
- Use of anticoagulant therapy(90 days)
- Transfusion-related serious adverse events(90 days)
研究者
Vibeke Lind Jørgensen
MD, pHD, consultant
Rigshospitalet, Denmark