Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Coagulability
研究概览
简要总结
The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.
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
- •Patients with Covid-19
- •non-opposition of the patient to participate
排除标准
- •Non-Covid-19 acute respiratory distress syndrome
- •Non-Covid septicemia
- •Pregnant women
- •Breastfeeding women
- •Protected vulnerable adults
结局指标
主要结局
Coagulability
时间窗: Day 15
TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)
Venous thrombotic event (VTE) or arterial thrombosis
时间窗: Day 15
Occurence of VTE or arterial thrombosis during hospitalization : * Pulmonary embolism diagnosed with CT scan * Venous or arterial thrombosis diagnosed with ultrasound exam
次要结局
未报告次要终点
