Effects of Immunomodulation With Interleukin-6 Antagonists on the Coagulation System in Critically-ill Covid-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in the lysis time
研究概览
简要总结
The emerging SARS-COV2 virus has shed a new light on the cross-talks between the immune and the hemostatic system. In this study we aim to evaluate the dynamic change in coagulation caused by the modulation of the inflammatory response by interleukin-6 antagonist as assessed by viscoelastic methods in critically ill COVID-19 patients. Furthermore we try to draw attention to possible associations between the endothelial cell injury, inflammation and coagulation.
详细描述
The emerging SARS-COV2 virus has shed new light on the cross-talk between the immune and the hemostatic system. Pathophysiologically in COVID-19 infection the thrombo-inflammatory process is initiated by the host's exaggerated systemic inflammatory response, also called "dysregulated immune response" that activates both the inflammatory and the coagulation cascade directly by inflammatory mediators and indirectly by causing endothelial cell injury. These mechanisms altogether contribute to the imbalance of the hemostasis that is characterized by a procoagulant state.
In this multicenter prospective observational study, we aim to evaluate the dynamic change in coagulation as a result of immunomodulation by interleukin-6 antagonists in critically ill COVID-19 patients. We will assess the hemostatic system by a viscoelastic hemostasis assay (Clotpro, Haemonetics Corporation, Boston). Furthermore, we try to draw attention to possible associations between endothelial cell injury, inflammation, and coagulation. To compare these parameters we will draw blood for analysis before administration of IL-6 antagonist then 24h after, 48h after, and 7 days after.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years old)
- •Clinical diagnosis of SARS-CoV2 infection with rtPCR confirmation
- •Disease severity with the indication of immunomodulation therapy with interleukin-6 antagonist: acute respiratory failure that requires invasive, noninvasive ventilation , or high flow nasal oxygen therapy with the following parameters: FiO2 > 0,4, flow > 30L/min and C Reactive Protein > 75 mg/L
排除标准
- •The patient had previously been administered one of the following immunomodulating drug: anakinra, tocilizumab, sarilumab
- •Presence of any condition or drug in the medical history that can lead to immunosuppression
- •Suspicion of infection (active tuberculosis, bacterial, viral, fungal) or level of procalcitonine higher than 0,5 ng/ml at the enrollment of the patient
- •Number of thrombocyte lower than 50 x 109 / L
- •More than >120 hours passed between the admission to the ICU and the administration of interleukin-6 antagonist
- •Administration of any of the following drugs the week before or during the study: fibrinolytic therapy, factor products (PCC, ATIII, FVIIa, FXIII), fibrinogen, desmopressin, tranexamic acid, blood products (FFP, thrombocyte concentrate)
- •Pregnancy
- •The patient or his legal guardian does not sign the consent
研究组 & 干预措施
Critically ill COVID-19 patients
Patients in ICU due to critical COVID-19 infection, who receive early (within the first 24 hours, but no later than 48 hours after intubation) IL-6 antagonist therapy at the consultant's discretion.
干预措施: IL6 Antagonist (Drug)
结局指标
主要结局
Change in the lysis time
时间窗: 48 hours
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis time (LT).
Change in the lysis onset time
时间窗: 48 hours
Change of the fibrinolytic system before (T0) and after immunomodulation therapy, measured by the lysis onset time (LOT).
次要结局
- Change in the lysis time(24 hours and 7 days)
- Change in the lysis onset time(24 hours and 7 days)
- Change in Clotpro assay(24 hours, 48 hours, and 7 days)
- Correlation between procalcitonin and Clotpro(24 hours, 48 hours, and 7 days)
- Correlation between C reactive protein and Clotpro(24 hours, 48 hours, and 7 days)
- Correlation between ferritin and Clotpro(24 hours, 48 hours, and 7 days)
- Correlation between lactate dehydrogenase and Clotpro(24 hours, 48 hours, and 7 days)
- Correlation between syndecan-1 and Clotpro(24 hours, 48 hours, and 7 days)
- Correlation between thrombomodulin and Clotpro(24 hours, 48 hours, and 7 days)