Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT04364412
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1198}, 'targetDuration': '15 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-26', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate in patients admitted for acute lower GI bleeding', 'timeFrame': '4 weeks', 'description': 'Number of deaths among the study cohort'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower GI Bleeding']}, 'referencesModule': {'references': [{'pmid': '33509737', 'type': 'DERIVED', 'citation': 'Radaelli F, Frazzoni L, Repici A, Rondonotti E, Mussetto A, Feletti V, Spada C, Manes G, Segato S, Grassi E, Musso A, Di Giulio E, Coluccio C, Manno M, De Nucci G, Festa V, Di Leo A, Marini M, Ferraris L, Feliziani M, Amato A, Soriani P, Del Bono C, Paggi S, Hassan C, Fuccio L. Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter, prospective, cohort study. Dig Liver Dis. 2021 Sep;53(9):1141-1147. doi: 10.1016/j.dld.2021.01.002. Epub 2021 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'Unlike upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5).\n\nPresent multicentre, prospective, observational study was designed to explore these areas, to assess variations in practice management and to identify factors associated with patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive, unselected outpatients acutely admitted for LGIB or developing LGIB during hospital stay (inpatients) were eligible for inclusion if they fulfilled the following criteria: i) age \\> 18 years; ii) recent (\\< 3 days) onset of overt bleeding with bright or dark blood or clots per rectum or melaena without hematemesis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with acute lower GI bleeding\n\nExclusion Criteria:\n\n* age below 18 years\n* bleeding patients with an upper GI source'}, 'identificationModule': {'nctId': 'NCT04364412', 'acronym': 'ALIBI', 'briefTitle': 'Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy', 'organization': {'class': 'OTHER', 'fullName': 'Valduce Hospital'}, 'officialTitle': 'Acute Lower gastroIntestinal BleedIng (ALIBI Study): a Multicentre Prospective, Cohort Study', 'orgStudyIdInfo': {'id': '70/2018'}}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Como', 'country': 'Italy', 'facility': 'Valduce Hospital', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valduce Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Gastroenterology Department', 'investigatorFullName': 'Franco Radaelli', 'investigatorAffiliation': 'Valduce Hospital'}}}}