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临床试验/NCT04751357
NCT04751357Unknown不适用

Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
1
主要终点
Correlation of ECA-Test CT with Argatroban Plasma Concentration

研究概览

简要总结

Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.

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

入选标准

  • Continuous infusion of Argatroban in routine clinical use according to local standard of care
  • Expected length of stay at ICU > 4 days

排除标准

  • Heparin infusion in the last fourhours

结局指标

主要结局

Correlation of ECA-Test CT with Argatroban Plasma Concentration

时间窗: ECA-Test CT and Argatroban Plasma Concentration will be measured on five consecutive days starting with inclusion in the study on day 0.

Correlation of ECA-Test CT with Argatroban Plasma Concentration on five consecutive days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Georg Scheriau

Principal investigator

Medical University of Vienna

研究点 (1)

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