Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04701905
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective analysis of the management of neurosurgical pathologies in a health crisis situation of the Covid-19 pandemic', 'timeFrame': 'The files analysed retrospectily from March 16, 2020 to June 15, 2020 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 Pandemic', 'Coronavirus', 'Sars-cov-2'], 'conditions': ['COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.\n\nThe restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.\n\nA knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient entering the neurosurgery care sector requiring treatment between 03/16/2020 and 06/15/2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged over 18;\n* Entering the neurosurgery care sector requiring support between 03/16/2020 and 06/15/2020;\n* Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.\n\nExclusion Criteria:\n\n* Subject having expressed opposition to participating in the study\n* Subject under guardianship or guardianship\n* Subject under safeguard of justice'}, 'identificationModule': {'nctId': 'NCT04701905', 'acronym': 'NeurochirCOVID', 'briefTitle': 'The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19', 'orgStudyIdInfo': {'id': '7780'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François PROUST, MD, PhD', 'role': 'CONTACT', 'email': 'francois.proust@chru-strasbourg.fr', 'phone': '33 3 88 12 76 12'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}, {'name': 'François PROUST, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Salvatore Chibbaro, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helene Cebula, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irene Ollivier, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Neurosurgery - Strasbourg University Hospitals', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'François PROUST, MD, PhD', 'role': 'CONTACT', 'email': 'francois.proust@chru-strasbourg.fr', 'phone': '33 3 88 12 76 12'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}], 'overallOfficials': [{'name': 'François PROUST, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery - Strasbourg University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}