Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients with SARS-Cov-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- on-treatment platelet reactivity
研究概览
简要总结
The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes
详细描述
Preliminary evidences suggested that patients with SARS-Cov-2 infection and concomitant presence of cardiovascular risk factors (i.e. arterial hypertension) and/or cardiovascular history (i.e. prior myocardial infarction) are at poor prognosis. The first reports from China suggested in patients with SARS-Cov-2 infection a heightened inflammatory burden associated with significant changes in coagulative status (i.e. low platelet count, increased D-dimer) and dysfunction of micro-vessels in pulmonary circulation.
No data are available about patterns and changes in platelet reactivity, activation of coagulation factors and endothelial function during SARS-Cov-2 infection.
The present study is ideated to fill this gap. Patients with moderate to severe respiratory failure due to SARS-Cov-2 infection will be enrolled. One blood sample will be obtained from each patient at the early, mid and late stage of disease. Several markers of platelet, coagulation and endothelial function will be related with laboratory, clinical, electrocardiographic, imaging (transthoracic echocardiogram, pulmonary ultrasonography, computed tomography) and outcome data.
To better describe typical patterns of disease regarding inflammation, platelet function and coagulation alteration, data from cases will be compared with control groups negative for SARS-CoV-2 infection, but with ST-segment elevation myocardial infarction or moderate-severe respiratory failure due to other agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Technicians performing assays will be blinded to stage of the infection and outcomes
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
- •Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 <200)
- •Diagnosis of SARS-CoV-2 infection + one of the following
- •invasive mechanical ventilation (cohort A)
- •non invasive mechanical ventilation (cohort B)
- •only oxygen support
排除标准
- •Previous chronic use of P2Y12 inhibitors
- •Need for chronic oral anti-coagulation therapy
- •Know disorder of coagulation or platelet function
结局指标
主要结局
on-treatment platelet reactivity
时间窗: late stage of disease (>14 days)
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
次要结局
- respiratory function(12-month)
- cardiac function(12-month)
- apoptosis rate in human umbilical vein endothelial cells (HUVEC)(mid stage of disease (96 hours - 14 days))
- Nitric oxide (NO) intracellular levels(mid stage of disease (96 hours - 14 days))
- reactive oxygen species (ROS) levels(late stage of disease (>14 days))
- coagulation factors levels(late stage of disease (>14 days))
- clinical outcome(12-month)
研究者
Gianluca Campo
Associate Professor
University Hospital of Ferrara