Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-31 @ 8:23 AM
Study NCT ID:
NCT05589103
Status:
UNKNOWN
Last Update Posted:
2022-10-21
First Post:
2022-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1692}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propensity score on the factors influencing the taking of antiplatelet agents.', 'timeFrame': 'Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head Trauma Injury', 'Head Trauma', 'Traumatic Intracranial Hemorrhage', 'Antiaggregants, Platelet'], 'conditions': ['Head Trauma Injury']}, 'descriptionModule': {'briefSummary': "The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.\n\nThe responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.\n\nThe hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (≥18 years old) victim of mild head trauma visiting the emergency room of the Strasbourg University Hospital during 2017.', 'eligibilityCriteria': 'Inclusion criteria\n\n* Adult patient (≥18 years old)\n* Visit to the emergency room of the Strasbourg University Hospital during 2017\n* Victim of mild head trauma\n* Patient who has given their consent to the reuse of their data for the purposes of this research.\n\nNon-inclusion criteria\n\n* Patient who expressed their opposition to participating in the study\n* Subject under safeguard of justice\n* Subject under guardianship or curatorship\n* Patient on anticoagulant\n* Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)'}, 'identificationModule': {'nctId': 'NCT05589103', 'acronym': 'Trauma-Head', 'briefTitle': 'Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.', 'orgStudyIdInfo': {'id': '7409'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florent BAICRY, MD', 'role': 'CONTACT', 'email': 'florent.baicry@chru-strasbourg.fr', 'phone': '33 3 69 55 03 86'}, {'name': 'Florent BAICRY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Quentin DELLENBACH, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierrick LE BORGNE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pascal BILBAULT, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'accueil des urgences - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Florent BAICRY, MD', 'role': 'CONTACT', 'email': 'florent.baicry@chru-strasbourg.fr', 'phone': '33 3 69 55 03 86'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}