Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-05 @ 1:03 AM
Study NCT ID:
NCT03934112
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2019-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival at 90 days after leaving ICU', 'timeFrame': 'Day 90', 'description': 'All-cause mortality 90 days after leaving ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transfusion Related Complication']}, 'descriptionModule': {'briefSummary': "This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria.\n\nThese data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies.\n\nIt will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated in medical and surgical resuscitation units of Besançon and Dijon university hospitals during the study period (from 01/01/2012 to 31/12/2017) are concerned.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient admitted to medical and surgical resuscitation units of Besançon and Dijon university hospitals, all causes considered\n* Patient admitted between 1st January 2012 to 31st December 2017'}, 'identificationModule': {'nctId': 'NCT03934112', 'acronym': 'PATMORE', 'briefTitle': 'Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care', 'orgStudyIdInfo': {'id': 'API/2016/72'}}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime Desmaret', 'role': 'CONTACT', 'email': 'mdesmaret@chu-besancon.fr', 'phone': '00000000'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Maxime Desmarets, PhD', 'role': 'CONTACT', 'email': 'maxime.desmarets@univ-fcomte.fr', 'phone': '0033 381 218 359'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}