Actively Recruiting
Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patients Taking Direct Oral Anticoagulants
Led by Masaryk University · Updated on 2025-09-10
70
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Masaryk University
Lead Sponsor
B
Brno University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the risk of intramuscular hematomas after needle electromyography (EMG) in patients who are taking direct oral anticoagulants (DOACs). The study aims to determine whether needle EMG is a safe procedure for these patients and if it poses any risk of hematoma formation at the muscles where the EMG needle was used. This observational study is sponsored by Masaryk University and focuses on patients using DOAC therapy undergoing needle EMG for various reasons. Participants in the study will undergo a needle EMG procedure followed by an ultrasound examination approximately 30 minutes later. This ultrasound is used to check for any intramuscular hematomas at the sites where the EMG needle was inserted. The study involves patients who have confirmed daily and recent intake of DOACs without other antithrombotic drug therapies. The primary outcome being measured is the risk of developing intramuscular hematomas within seven days after the needle EMG. During the study, participants will be monitored for hematoma development using ultrasound imaging shortly after EMG and tracked for seven days following the procedure. The study collects data on any adverse reactions related to the needle EMG in patients on DOAC therapy. Participants must provide informed consent and comply with all study procedures. The total duration of observation includes the immediate post-EMG ultrasound and a follow-up period to assess safety outcomes.
CONDITIONS
Brief Title
Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must understand the nature of the study and provide signed, dated informed consent before any study procedures
- Willing and able to comply with all protocol procedures
- Confirmed daily and recent intake of direct oral anticoagulants in standard dosing
- Not taking any other antithrombotic drug therapy such as aspirin, clopidogrel, ticagrelol, low molecular weight heparin, or a second direct anticoagulant
You will not qualify if you...
- Any significant medical or psychiatric condition or history that may interfere with participation or increase risk, as judged by the investigator
- Recent use of other antithrombotic drug therapies including aspirin, clopidogrel, ticagrelol, low molecular weight heparin, or a second direct anticoagulant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo needle EMG while on direct oral anticoagulants to evaluate hematoma risk.
1 visit (in-person)
Duration - 7 days
Participants are monitored for intramuscular hematoma risk for seven days following the needle EMG.
Follow-up assessments over 7 days
Trial Site Locations
Total: 2 locations
1
University Hospital Brno
Brno, Czech Republic, Czechia, 62500
Actively Recruiting
2
University hospital Brno
Brno, Czech Republic, Czechia, 62500
Actively Recruiting
Research Team
A
Adam Betík, MD
E
Eva Vlckova, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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