A Study to Determine the Inter/Intra Observer and Intra-Subject Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Distribution and variability of WBCT measurements
研究概览
简要总结
The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.
详细描述
Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant).
Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent form
- •Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -
排除标准
- •Subjects who cannot communicate reliably with the Investigator
- •History of major bleeding or major trauma within the 6 months prior to signing informed consent
- •Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids)
- •Significant infection or known inflammatory process in the 2 weeks prior to screening
- •Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent
- •Treatment with any investigation product or therapy within 30 days prior to screening
- •Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling
- •Unwilling to comply with the procedures in the protocol
- •Currently enrolled in any other study -
研究组 & 干预措施
Blood Sample
Blood will be sampled by direct venipuncture on 8 occasions.
干预措施: Blood drawn by direct venipuncture (Other)
Blood Sample
Blood will be sampled by direct venipuncture on 8 occasions.
干预措施: edoxaban (Drug)
Blood Sample
Blood will be sampled by direct venipuncture on 8 occasions.
干预措施: Enoxaparin (Drug)
Blood Sample
Blood will be sampled by direct venipuncture on 8 occasions.
干预措施: Saline sham (Drug)
结局指标
主要结局
Distribution and variability of WBCT measurements
时间窗: 1 day
Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban
次要结局
未报告次要终点