Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy (U-HAND)

Masaryk University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07166302

870177

PIG I/22 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

DOAC patients

Description:

Patients using direct anticoagulants and undergoing needle EMG for whatever reason