Direct Acting Anticoagulant Adverse ReactionU-HANDNCT07166302
Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy
An observational study of Direct Acting Anticoagulant Adverse Reaction and Needle Injury, run by Masaryk University at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Direct Acting Anticoagulant Adverse Reaction, Needle Injury, EMG
- How many people
- 70 participants
- Where
- 2 sitesCzechia
- Study dates
- Sep 2025to 31 Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing needle EMG examination in EMG laboratory
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Brno
Brno, Czech Republic, 62500
Adam Betík, MD, +420532232503, adam.betik@gmail.com
Eva Vlckova, MD, +420532233221, vlckova.eva@fnbrno.cz
- Recruiting
University hospital Brno
Brno, Czech Republic, 62500
About this study
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
- Keywords
- electromyography, hematoma, ultrasonography, anticoagulants
- Medical subject headings
- Peripheral Nervous System Diseases, Mononeuropathies, Polyneuropathies, Neuromuscular Diseases, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DOAC patients | Patients using direct anticoagulants and undergoing needle EMG for whatever reason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramuscular hematoma risk
Ultrasound evaluation of intramuscular hematoma formation after needle EMG in DOAC patients
Measured: seven days since the needle EMG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study startSep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Acting Anticoagulant Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital
- Responsible party
- Principal investigator, Adam Betik, Masaryk University
- Investigators
- Eva Vlckova, MD, Study chair, Masaryk University, University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166302
- Sponsor's protocol ID
- 870177
- Other IDs
- PIG I/22
- Acronym
- U-HAND
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy
- ClinicalTrials.gov ID
- NCT07166302
- Acronym / sponsor ID
- U-HAND / 870177
- Conditions
- Direct Acting Anticoagulant Adverse Reaction, Needle Injury, EMG, Peripheral Neuropathies, Mononeuropathies, Polyneuropathies
- Keywords
- electromyography, hematoma, ultrasonography, anticoagulants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital
- Study start
- Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOAC patients | – | –Patients using direct anticoagulants and undergoing needle EMG for whatever reason |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing needle EMG examination in EMG laboratory
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intramuscular hematoma risk
Time frame: seven days since the needle EMG
Ultrasound evaluation of intramuscular hematoma formation after needle EMG in DOAC patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Vlckova, MD study chair
Masaryk University, University Hospital Brno
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Direct Acting Anticoagulant Adverse Reaction and Needle Injury, run by Masaryk University at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Betík, MD (+420532232503, betik.adam@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intramuscular hematoma risk (time frame: seven days since the needle EMG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.