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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patients undergoing needle EMG examination in EMG laboratory

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: DOAC patients

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Masaryk University

Lead sponsor

Brno University Hospital

Collaborator