Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT04296435
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding
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': 1320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'During the years 2017 and 2018', 'description': 'In-hospital mortality and at 30 days after early gastroscopy will be assessed through clinical history observation, within the study period'}], 'secondaryOutcomes': [{'measure': 'Entry Duration', 'timeFrame': 'During the years 2017 and 2018', 'description': 'The time between admission and discharge'}, {'measure': 'Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.', 'timeFrame': 'During the years 2017 and 2018', 'description': 'It will be evaluated using the Rockall scale'}, {'measure': 'Type of endoscopic treatments', 'timeFrame': 'During the years 2017 and 2018', 'description': 'Hemostasis can be performed by applying different techniques or a combination of them'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weekend effect', 'non-varicose upper gastrointestinal bleeding'], 'conditions': ['Acute Upper Gastrointestinal Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that the mortality of patients with non-varicose upper gastrointestinal bleeding after performing early gastroscopy who are admitted on weekends and night hours is higher than those admitted on weekdays or during daytime hours.', 'detailedDescription': 'The aim of the study is to evaluate the impact of the schedule (day or night) and the day of admission (working or weekend / night) on the mortality of patients with non-varicose upper gastrointestinal bleeding after performing an early gastroscopy.\n\nA retrospective observational study will be carried out in patients admitted to the bleeding unit of the Santa Creu I Sant Pau Hospital, where we observed hospital mortality and 30 days after performing an early gastroscopy, the duration of admission, signs of hemorrhagic activity in a period of less than 12 h. After early gastroscopy and types of endoscopic treatments, data will be collected by reviewing medical records.\n\nThe number of patients expected to be included in this study is 1320 patients. Patients will be included the day they enter the bleeding unit for an early gastroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with non-varicose upper gastrointestinal bleeding and admitted to the Bleeding Unit of the Santa Creu and Sant Pau hospital during 2017 and 2018 to perform an early gastroscopy. In addition, patients must meet the following inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients older than 18 years.\n* Patients admitted to the Bleeding Unit with a diagnosis of upper gastrointestinal bleeding.\n* Patients who have undergone an early endoscopy to determine the source of bleeding.\n* In case of readmissions during the study period, we consider only the admission closest to his death or discharge.\n\nExclusion criteria:\n\n* Patients diagnosed with gastrointestinal bleeding varicose.\n* Patients who present with gastrointestinal bleeding and did not perform early gastroscopy (during the first 24 hours)\n* Patients admitted for different medical conditions, who developed upper gastrointestinal bleeding during the course of hospital stay.'}, 'identificationModule': {'nctId': 'NCT04296435', 'briefTitle': 'The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Observational Study About the Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Gastrointestinal Bleeding', 'orgStudyIdInfo': {'id': 'IIBSP-FIN-2018-50'}}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luzdivina Perez Garcia', 'role': 'CONTACT', 'email': 'Lperez@santpau.cat', 'phone': '699940025'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Luzdivina Perez Garcia', 'role': 'CONTACT', 'email': 'Lperez@santpau.cat', 'phone': '699940025'}], 'overallOfficials': [{'name': 'Luzdivina Perez Garcia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}