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RecruitingNCT07166302U-HANDUpdated Sep 10, 2025

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

An observational study in Direct Acting Anticoagulant Adverse Reaction, Needle Injury and EMG, sponsored by Masaryk University. Recruiting at 2 sites in Czechia. Per ClinicalTrials.gov, last updated 2025-09-10.

Primary conditionPolyneuropathiesRegistry: Peripheral Nervous System DiseasesReclassifiedWhy we changed it
Registry
Peripheral Nervous System Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Polyneuropathies
Why
  1. The study's listed conditions name Polyneuropathies, a narrower term within Peripheral Nervous System Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Masaryk University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Sex
All
01

Study summary

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.

02

Conditions studied

  • Direct Acting Anticoagulant Adverse Reaction
  • Needle Injury
  • EMG
  • Peripheral Neuropathies
  • Mononeuropathies
  • Polyneuropathies
  • Neuromuscular Diseases (NMD)

Keywords

  • electromyography
  • hematoma
  • ultrasonography
  • anticoagulants
03

In context

Polyneuropathies Reclassified

133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.

This study's planned enrollment of 70 is below the median of 100 across 53 observational studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

Masaryk University is the lead sponsor of 47 studies on the registry; 20 are open to participants now.

Compared within Polyneuropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Nervous System Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing needle EMG examination in EMG laboratory

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must understand the nature of the study and must provide signed and dated written 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

Exclusion Criteria:

  • Any 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • DOAC patients

    Patients using direct anticoagulants and undergoing needle EMG for whatever reason

06

What researchers measure

Primary outcomes

  1. Intramuscular hematoma risk

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

    Time frame: seven days since the needle EMG

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07166302
Lead sponsor
Masaryk University
Collaborators
Brno University Hospital
Responsible party
Adam Betik (MD, Masaryk University) — Principal investigator
First posted
Sep 10, 2025
Start date
Sep 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 10, 2025

Study contacts

Adam Betík, MD
Contact
betik.adam@fnbrno.cz
+420532232503
Eva Vlckova, MD
Contact
vlckova.eva@fnbrno.cz
+420532233221
Eva Vlckova, MD
study chair · Masaryk University, University Hospital Brno

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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