跳至主要内容
临床试验/NCT05128110
NCT05128110已完成不适用

Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests

研究概览

简要总结

Anticoagulation monitoring is done by monitoring the ACT (Activated Clotting Time) with an objective greater than 300 s. Until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. However, 3 recent randomized studies concerning the 3 DOACs available suggest that treatment should not be interrupted during the entire operative period. The operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. Under these conditions, ACT monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. It was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of UFH (Unfractionated Heparin) during the procedure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • Patients over 18 years-old
  • with an atrial fibrillation
  • Operated for an atrial fibrillation procedure in the University hospital of Strasbourg
  • Without interruption of the direct oral anticoagulant
  • For whom extended biological assessment has been made in routine practice

排除标准

  • Patients who refused the use of their data for this study

结局指标

主要结局

Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests

时间窗: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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