Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 3
- 主要终点
- Overall Sensitivity and Specificity of Pefakit and Hemosil.
研究概览
简要总结
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States Food and Drug Administration (FDA) 510(k) submission.
详细描述
Standard of Care Study. Objective is to monitor the patients' heparin levels under treatment with continuous unfractionated heparin infusions. Blood samples collections (4 ml) are required routinely. A proportion of this standard sample (leftover plasma) will be used for study purposes. About three samples will be analyzed which are collected within 2 - 4 days. Time points for blood sample collections will be defined by the treating physician according the local standard of care and will be associated exclusively to clinical considerations. Results of the Pefakit® PiCT® UC assay will NOT be used to take therapeutic decisions for study subjects.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects receiving a continuous infusion with UFH
- •Subjects who have given written informed consent (unless written informed consent is waived by local regulations or local EC/IRB)
排除标准
- •Subjects treated with any other anticoagulants other than UFH
- •Subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks
- •Subjects who are known to have a congenital bleeding disorder
- •Subjects known to present unexplained prolongations of clotting time
- •Subjects known to have coagulation factor deficiencies
- •Patient participating or who has participated within one month from enrolment in another investigational study
结局指标
主要结局
Overall Sensitivity and Specificity of Pefakit and Hemosil.
时间窗: within 2 - 4 days
Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)
次要结局
未报告次要终点