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

NCT07166302 | Recruiting

• 2 other identifiers: 870177PIG I/22
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

electromyography; hematoma; ultrasonography; anticoagulants

Outcome Measures

Primary Outcomes (1)

• Intramuscular hematoma risk

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

  seven days since the needle EMG

Study Arms (1)

DOAC patients

Patients using direct anticoagulants and undergoing needle EMG for whatever reason

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing needle EMG examination in EMG laboratory

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masaryk University: lead
• University Hospital Brno: collaborator

Study Sites (2)

University Hospital Brno

Brno, Czech Republic, 62500, Czechia

RECRUITING

University hospital Brno

Brno, Czech Republic, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Mononeuropathies; Polyneuropathies; Neuromuscular Diseases; Hematoma

Condition Hierarchy (Ancestors)

Nervous System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Vlckova, MD

  Masaryk University, University Hospital Brno

  STUDY CHAIR

Central Study Contacts

Adam Betík, MD

CONTACT

+420532232503; betik.adam@fnbrno.cz

Eva Vlckova, MD

CONTACT

+420532233221; vlckova.eva@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)