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临床试验/NCT07166302
NCT07166302招募中不适用

Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy

Masaryk University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Intramuscular hematoma risk

研究概览

简要总结

Approximately 30 minutes after needle EMG, patients who are taking direct oral anticoagulants (DOACs) will undergo an ultrasound examination to evaluate for the presence of possible intramuscular hematomas at the muscles where the EMG needle was inserted. These hematomas are considered a potential adverse effect of needle EMG.

The aim of the study is to determine whether needle EMG can be considered a safe procedure in this group of patients, without posing a risk of intramuscular hematoma formation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects must understand the nature of the study and must provide signed and dated written informed consent prior to conducting any study-related procedures
  • Willing and able to comply with all protocol procedures
  • subjects confirmed the daily (and recent) intake od direct anticoagulants in strandard dosing.
  • no other antitrombotic drug therapy (e.g. acetylsalicyl acid, clopidogrel, ticagralol, low molecular weight heparin or second direct anticoagulant) is taken.

排除标准

  • Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject
  • other antitrombotic drug therapy (e.g. acetylsalicyl acid, clopidogrel, ticagralol, low molecular weight heparin or second direct anticoagulant) is recently taken.

结局指标

主要结局

Intramuscular hematoma risk

时间窗: seven days since the needle EMG

Ultrasound evaluation of intramuscular hematoma formation after needle EMG in DOAC patients

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

Adam Betik

MD

Masaryk University

研究点 (2)

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