Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Quantra Clot Stiffness results
研究概览
简要总结
This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.
详细描述
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QPlus Cartridge can measure hypocoagulable and hypercoagulable conditions resulting from the functional interaction of the enzymatic and cellular components of coagulation and therefore, can be invaluable for longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response to anticoagulants.
This single-center, prospective, observational pilot study will characterize changes in the coagulation status of patients with COVID-19 infection during their hospital stay using the Quantra QPlus System.
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
- •Subject is ≥ 18 years of age
- •Subject has a diagnosis of COVID-19 and has been admitted to the hospital
- •Subject has one or more risk factors for a poor outcome with COVID-10 disease: advanced age (>=60 years), morbid obesity, diabetes, COPD, CAD
- •Subject, or subject's legally authorized representative is willing and agrees to provide informed consent.
排除标准
- •Subject is younger than 18 years of age
- •Subject is pregnant
- •Subject is incarcerated.
- •Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- •Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
结局指标
主要结局
Quantra Clot Stiffness results
时间窗: 1 to 24 hours prior to discharge from hospital
Coagulation function assessed by the Quantra
Quantra Clot Time results
时间窗: 1 to 24 hours prior to discharge from hospital
Coagulation function assessed by the Quantra
次要结局
未报告次要终点