Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- PCM Clotting Time (CT)
研究概览
简要总结
This study is intended to define the PCM normal laboratory range.
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
- 是
入选标准
- •Age ≥ 18 years old
- •Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m2m with body weight ≥ 50 kg (106 lb)
- •Normal vital signs at screening
排除标准
- •Current daily tobacco use or previous recreational drug use
- •Pregnant or lactating at the time of the study
- •Currently taking any medications known to affect coagulation
- •History of excessive bleeding from minor trauma that required medical attention, spontaneous nose bleeds that required medical attention or multiple spontaneous abortions, liver disease, blood related diseases, congenital or acquired coagulopathies or thromboembolic diseases
- •Current diagnosis of cancer
结局指标
主要结局
PCM Clotting Time (CT)
时间窗: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured.
Clot Formation Time (CFT)
时间窗: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.
Alpha Angle (AA)
时间窗: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, alpha angle (AA) will be measured. To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured.
Maximum Clot Firmness (MCF)
时间窗: Testing to be initiated within 4 minutes of sample collection
To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured.
30-minutes Lysis after CT (LI30)
时间窗: Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT
To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured.
45-minutes Lysis after CT (LI45)
时间窗: Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT
To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured.
次要结局
未报告次要终点