Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT07166302
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intramuscular hematoma risk', 'timeFrame': 'seven days since the needle EMG', 'description': 'Ultrasound evaluation of intramuscular hematoma formation after needle EMG in DOAC patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electromyography', 'hematoma', 'ultrasonography', 'anticoagulants'], 'conditions': ['Direct Acting Anticoagulant Adverse Reaction', 'Needle Injury', 'EMG', 'Peripheral Neuropathies', 'Mononeuropathies', 'Polyneuropathies', 'Neuromuscular Diseases (NMD)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing needle EMG examination in EMG laboratory', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must understand the nature of the study and must provide signed and dated written informed consent prior to conducting any study-related procedures\n* Willing and able to comply with all protocol procedures\n* subjects confirmed the daily (and recent) intake od direct anticoagulants in strandard dosing.\n* no other antitrombotic drug therapy (e.g. acetylsalicyl acid, clopidogrel, ticagralol, low molecular weight heparin or second direct anticoagulant) is taken.\n\nExclusion Criteria:\n\n* 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\n* other antitrombotic drug therapy (e.g. acetylsalicyl acid, clopidogrel, ticagralol, low molecular weight heparin or second direct anticoagulant) is recently taken."}, 'identificationModule': {'nctId': 'NCT07166302', 'acronym': 'U-HAND', 'briefTitle': 'Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'Ultrasound Evaluation of Hematoma Risk After Needle EMG in Patient on DOAC Therapy', 'orgStudyIdInfo': {'id': '870177'}, 'secondaryIdInfos': [{'id': 'PIG I/22', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Brno'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'DOAC patients', 'description': 'Patients using direct anticoagulants and undergoing needle EMG for whatever reason'}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'Czech Republic', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Adam Betík, MD', 'role': 'CONTACT', 'email': 'adam.betik@gmail.com', 'phone': '+420532232503'}, {'name': 'Eva Vlckova, MD', 'role': 'CONTACT', 'email': 'vlckova.eva@fnbrno.cz', 'phone': '+420532233221'}], 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '62500', 'city': 'Brno', 'state': 'Czech Republic', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'University hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'Adam Betík, MD', 'role': 'CONTACT', 'email': 'betik.adam@fnbrno.cz', 'phone': '+420532232503'}, {'name': 'Eva Vlckova, MD', 'role': 'CONTACT', 'email': 'vlckova.eva@fnbrno.cz', 'phone': '+420532233221'}], 'overallOfficials': [{'name': 'Eva Vlckova, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Masaryk University, University Hospital Brno'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Brno', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Adam Betik', 'investigatorAffiliation': 'Masaryk University'}}}}