Ultrasound check for intramuscular bleeding after needle EMG in people taking DOACs
Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy
Ultrasound will be used about 30 minutes after a needle EMG to see if people taking direct oral anticoagulants (DOACs) develop intramuscular hematomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Sex | All |
| Sponsor | Masaryk University Academic / other |
| Locations | 2 sites (Brno, Czech Republic and 1 other locations) |
| Trial ID | NCT07166302 on ClinicalTrials.gov |
What this trial studies
This is an observational protocol enrolling people who are taking DOACs and who undergo needle electromyography (EMG). About 30 minutes after the EMG, an ultrasound exam of the muscles where needles were inserted will be performed to look for possible intramuscular hematomas. Subjects on any additional antithrombotic medications are excluded to isolate the effect of DOAC therapy. The goal is to determine whether routine needle EMG poses a bleeding risk in this patient group without altering their anticoagulant regimen.
Who should consider this trial
Good fit: Adults who take a direct oral anticoagulant at standard daily dosing, can give informed consent, are willing to comply with study procedures, and are not taking any other antithrombotic drugs are ideal candidates.
Not a fit: People taking additional antiplatelet or anticoagulant medications, or those with other bleeding disorders or conditions that increase bleeding risk, may not benefit from the study’s findings.
Why it matters
Potential benefit: If results show a low risk of hematoma, clinicians and patients may be reassured that needle EMG can be performed safely without stopping DOACs, reducing interruptions in anticoagulation care.
How similar studies have performed: Published data on hematoma risk after needle EMG in patients on DOACs is limited to small series and case reports, so this approach remains relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Brno, Czech Republic and 1 other locations
- University Hospital Brno — Brno, Czech Republic, Czechia (Recruiting)
- University hospital Brno — Brno, Czech Republic, Czechia (Recruiting)
Study contacts
- Study coordinator: Adam Betík, MD
- Email: betik.adam@fnbrno.cz
- Phone: +420532232503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.