Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04930120
Status:
UNKNOWN
Last Update Posted:
2021-06-22
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3060}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 year', 'description': 'Status alive or dead'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.', 'detailedDescription': 'In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients.\n\nAll transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severely ill COVID-19 patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 patients diagnosed biologically or by imaging\n* Admission in ICU between 03/13/2020 and 04/10/2020\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04930120', 'acronym': 'TRANSCOV', 'briefTitle': 'Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Ecole des Hautes Etudes en Santé Publique'}, 'officialTitle': 'TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units', 'orgStudyIdInfo': {'id': '20 CO 015 CZ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transferred group', 'description': 'The transferred group includes all severe COVID patients admitted in a French ICU ward and then transferred between the 03/13/2020 and 04/10/2020 to another ICU located outside the region of the initial ICU stay.', 'interventionNames': ['Other: Inter ICU long distance patient transfer']}, {'label': 'Control group', 'description': 'The control group includes patients selected out of those whose entire ICU care has taken place in one of the hospitals which transferred patients. Up to 4 control patients will be selected for each transferred patient.'}], 'interventions': [{'name': 'Inter ICU long distance patient transfer', 'type': 'OTHER', 'description': 'Individual or grouped transportation between ICU of severely ill patients using ambulance, plane, helicopter, train or boat, with specialist medical assistance.', 'armGroupLabels': ['Transferred group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35043', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Grimaud, Ph.D., M.D.', 'role': 'CONTACT', 'email': 'olivier.grimaud@ehesp.fr', 'phone': '02 99 02 2834', 'phoneExt': '33'}, {'name': 'Christophe Fermanian, Ph.D.', 'role': 'CONTACT', 'email': 'christophe.fermanian@ehesp.fr', 'phone': '02 99 02 24 69', 'phoneExt': '33'}], 'facility': 'EHESP', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Olivier Grimaud, Ph.D., M.D', 'role': 'CONTACT', 'email': 'olivier.grimaud@ehesp.fr', 'phone': '02 99 02 28 34', 'phoneExt': '33'}, {'name': 'Christophe Fermanian, Ph.D.', 'role': 'CONTACT', 'email': 'christophe.fermanian@ehesp.fr', 'phone': '02 99 02 24 69', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Olivier Grimaud, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ecole des Hautes Etudes en Santé Publique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ecole des Hautes Etudes en Santé Publique', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the deparment Quantitative Methods in Public Health', 'investigatorFullName': 'Olivier Grimaud', 'investigatorAffiliation': 'Ecole des Hautes Etudes en Santé Publique'}}}}