NCT02825394Unknown不适用
Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result
研究概览
简要总结
The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
- •Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
- •Age ≥ 18 years
- •Written informed consent by patient
排除标准
- •Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
- •Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
- •Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
- •Part A only: abnormal routine coagulation test values at baseline (defined by INR > 1.2, Quick < 70% or aPTT > 40 sec)
- •History of coagulopathy
结局指标
主要结局
Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result
时间窗: 24 hours
DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
次要结局
- Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels(24 hours)
- Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay(24 hours)
- Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay(24 hours)
- Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay(24 hours)
- Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay(24 hours)
- Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay(24 hours)
- Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay(24 hours)
- Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay(24 hours)
- Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay(24 hours)
- Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay(24 hours)
- Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay(24 hours)
- Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay(24 hours)
研究者
Dr. Sven Poli
MD MSc
University Hospital Tuebingen
研究点 (1)
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