NCT02798328已完成不适用
Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 4
- 主要终点
- Presence / Absence of DOAC Drug
研究概览
简要总结
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •≥ 18 years old
- •DOAC administered for a minimum of 7 days
排除标准
- •Genetic Bleeding disorders. Known or subsequently discovered inherited defects of coagulation (e.g. hemophilia or Von Willebrand disease)
- •Not known when last two DOAC doses were administered prior to blood draw
- •DOAC first administered (or resumed after temporary cessation) less than 7 days prior to blood draw
- •DOAC dosage outside of manufacturer's recommended range (e.g. study subject with renal impairment and supratherapeutic dose)
- •Heparin or LMWH administered within 7 days prior to blood draw
- •On any medications known to affect coagulation status and listed below
- •Bruising, wounds or scarring in the area of venipuncture
- •List of medications known to affect coagulation status
- •Vitamin K Antagonists [VKAs] Warfarin Phenprocoumon Acenocoumarol Tecarfarin [ATI-5923] Phenindione Anisindione Elinogrel Vorapaxar Atopaxar
- •Heparin and Heparins Unfractionated Heparin [UFH] LMWH Fondaparinux Idraparinux Danaparoid
- •Vasopressin Analogues DDAVP
- •Direct Thrombin [IIa] Inhibitors Hirudin Lepirudin Bivalirudin Argatroban
- •Defibrinating Agents Ancrod
结局指标
主要结局
Presence / Absence of DOAC Drug
时间窗: 1 week
次要结局
未报告次要终点
研究者
研究点 (4)
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