Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Method comparison: Deming regression analysis (PCM and ROTEM NATEM)
研究概览
简要总结
To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications
详细描述
The primary aim of this study is a performance evaluation of the PCM coagulation monitor in comparison to the ROTEM thromboelastometry system.
To include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as PT/PTT, INR) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.
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
- •Age 18 years or older
- •In opinion of investigator, absence of anything that precludes subject from being good study candidate
- •Informed consent
- •Order for measurement of hemostasis status of patients who are at risk for being hyper-coagulable or hypo-coagulable due to clinical diagnosis or medical need
排除标准
- •Previous enrollment in study
- •Incarcerated
- •Heparin infusion in prior 24 hours
结局指标
主要结局
Method comparison: Deming regression analysis (PCM and ROTEM NATEM)
时间窗: Parameter differences assessed at time of blood sampling
Deming regression will be used to compare the PCM and the ROTEM NATEM assay (which reports clotting time, speed of clot formation, maximal clot firmness and clot lysis)
次要结局
- Correlation between abnormalities(Parameter differences assessed at time of blood sampling)
- Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)(Parameter differences assessed at time of blood sampling)