Clinical Efficacy and Safety of Extracorporeal Blood Purification to Control Hyperinflammation and Hypercoagulability in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes in thrombocyte counts (10^3 counts/microL)
研究概览
简要总结
Several studies have suggested a potential clinical benefit of controlling hyper inflammation triggered by SARS-CoV-2/COVID-19. Blood purification, the removal of excessive proinflammatory mediators may control disease progression and support clinical recovery.
For this purpose, COVID-19 patients might benefit from treatment with AN69ST hemofilter based extracorporeal blood purification.
详细描述
COVID-19 disease progression is associated with dysregulated immunity, commonly referred to as cytokine storm, in particular, aberrant Interleukin (IL) 6 levels that promote numerous pathological downstream effects. Hyperinflammation is a well-established trigger of multiorgan failure, for example, acute kidney injury. Moreover, recent reports point to a link between hyper inflammation and COVID-19 induced coagulopathy as a result of increased production of clotting factors by the liver.
Despite several lines of evidence pointing to a potential clinical benefit of controlling hyperinflammation triggered by COVID-19, management of COVID-19 remains mostly supportive built around continuous respiratory support.
To this end, considering the underlying immunological character of COVID-19 disease and the high risk of SARS-CoV-2 hyperinflammation to trigger ARDS, hypercoagulability and Acute Kidney Injury (AKI) this study aims to monitor selected biochemical, immunological and coagulation parameters in combination with radiological imaging to guide clinical practice and to tailor therapy consisting of 1) early initiation of blood purification using the oXiris® (AN69ST) filter, 2) systemic heparinisation and 3) respiratory support
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Confirmed COVID-19 disease:
- •Atypical Pneumonia; X-Ray and/or Computed Tomography
- •≥ 1 oXiris® blood purification cycle
排除标准
- •Pregnancy
- •Heart failure; severe systolic dysfunction, left ventricular ejection fraction < 25% requiring urgent surgery
- •Aortic Aneurysms, dissection or rupture requiring urgent surgery
- •Recent Myocardial Infarction; cardiovascular disease patients requiring urgent surgery
结局指标
主要结局
Changes in thrombocyte counts (10^3 counts/microL)
时间窗: Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)
Systemic levels of thrombocytes are measured as a marker for disease severity. Measurement points: at admission, "before and after a blood purification cycle" and before discharge.
Changes in the coagulation marker Fibrinogen (g/L)
时间窗: Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)
Coagulation markers will be followed to assess the effect of systemic heparinisation, Measurement points, at admission, "before and after a blood purification cycle" and before discharge
Changes in cytokine levels of Interleukin (IL) 6, IL-8 and Tumor Necrosis Factor-α (pg/mL)
时间窗: Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)
Systemic levels of IL-6, IL-8 and TNF-α are evaluated to assess the effect of blood purification. Measurement points: at admission, "before and after a blood purification cycle" and before discharge
Changes in inflammatory markers; C-Reactive Protein (CRP) (mg/L)
时间窗: Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)
Systemic levels of proinflammatory mediators are measured as a marker for disease severity. Measurement points: at admission, "before and after a blood purification cycle" and before discharge.
ICU length of stay after admission (days)
时间窗: An expected average of 4 - 14 hospitalisation days or until hospital discharge (whichever comes first)
Duration of intensive care will be determined in relation to the number of blood purification cycles Patients will be followed for the duration of ICU stay.
次要结局
- Changes in the coagulation marker D-Dimers (ng/mL)(Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first))
- Changes in Neutrophil-to-Lymphocyte Ratio(Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first))
- Changes in the Activation Clotting Time (seconds).(Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first))