NCT06582563尚未招募不适用
Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times
Perosphere Technologies Inc.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
研究概览
简要总结
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
详细描述
Primary objectives of the planned whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In general, study participants must:
- •Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- •Be 18- to 80-years-of-age, inclusive, at time of consent.
- •Have suitable venous access for at least a single venipuncture.
- •Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion
排除标准
- •Eligible patients on anticoagulants must not:
- •Other than the condition for which a DOAC was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions.
- •Have a BMI> 40 or weight > 120kg.
- •Suffer from renal or hepatic insufficiency.
- •Suffer from any pathology that would contra-indicate in general DOAC medication.
- •Have a history of unexplained syncope.
- •Have a history within 6 months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
- •Consume more than 5 cigarettes per day.
- •If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- •If female is pregnant, breastfeeding, or planning to become pregnant during study
结局指标
主要结局
Clotting times of whole blood samples, measured on Perosphere Technologies' PoC Coagulometer devices
时间窗: Immediate
Whole Blood Clotting Time
次要结局
- Drug concentrations in collected blood samples as measured through anti-factor Xa (anti-Xa) assay(Immediate)
研究者
研究点 (1)
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