NCT07012291招募中不适用
Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants (DOACs) With the Perosphere ClotChek™ Coagulometer
Perosphere Technologies Inc.3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年6月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time.
研究概览
简要总结
The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC). The instrument performs a whole blood clotting time (WBCT) test using freshly drawn, non-citrated whole blood. The purpose of the present study is to characterize the performance of the Perosphere ClotChek™ as a quantitative measurement of the WBCT in patients taking one of the following Direct Oral Anticoagulants (DOACs), rivaroxaban or apixaban.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •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
- •Eligible patients on anticoagulants must have been on their anticoagulant therapy for at least one month.
排除标准
- •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, other than the condition for which a DOAC was prescribed.
- •Have a history of unexplained syncope.
- •Have a history within six months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
- •Consume more than five cigarettes per day.
- •If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
- •If female, be pregnant, breastfeeding, or planning to become pregnant during the study.
结局指标
主要结局
Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time.
时间窗: Day 1
次要结局
- To characterize performance of the ClotChek™ device via whole blood clotting time measurement within clinically relevant patient subgroups (eg renal or hepatic impairment).(Day 1)
研究者
研究点 (3)
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