Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Direct Acting Anticoagulant Adverse Reaction, Needle Injury, EMG, Peripheral Neuropathies. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Intramuscular hematoma risk [Time frame: seven days since the needle EMG]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Czechia · 2 centers
- University Hospital Brno — Brno
- University hospital Brno — Brno
Identifiers
NCT: NCT07166302 · 870177 · PIG I/22