Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04211194
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry for Upper Gastrointestinal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2999}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '30 days', 'description': 'Mortality rate from upper gastrointestinal bleeding and from any etiology'}], 'secondaryOutcomes': [{'measure': 'Rate of Reintervention', 'timeFrame': '30 days', 'description': 'Need for repeat endoscopic treatment for upper gastrointestinal bleeding'}, {'measure': 'Rate of Recurrence', 'timeFrame': '30 days', 'description': 'Recurrence of upper gastrointestinal bleeding following endoscopic treatment'}, {'measure': 'Rate of Readmission', 'timeFrame': '30 days', 'description': 'Need for readmission to hospital for treatment of upper gastrointestinal bleeding'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days', 'description': 'Length of hospitalization from index endoscopic procedure to discharge'}, {'measure': 'Costs', 'timeFrame': '30 days', 'description': 'Total hospital costs from admission for upper gastrointestinal bleeding'}, {'measure': 'Treatment success', 'timeFrame': '30 days', 'description': 'Successful treatment of upper gastrointestinal bleeding using endoscopic therapy as determined by a yes/no answer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peptic Ulcer Hemorrhage', 'Peptic Ulcer, Acute With Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate the data on all patients undergoing endoscopic therapy for upper gastrointestinal bleeding.', 'detailedDescription': "This project is being performed to evaluate the outcomes of patients undergoing endoscopic procedures for upper gastrointestinal bleeding at all AdventHealth hospitals in Central Florida. This information will enable quality control of patients undergoing treatment for upper gastrointestinal bleeding across all campuses in the AdventHealth system in Central Florida and hence improve the delivery ot care extended to the investigator's patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population will come from patient who are undergoing endoscopic treatment for upper gastrointestinal bleeding at AdventHealth Hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years of age or greater\n* Patient is undergoing endoscopic treatment for upper gastrointestinal bleeding\n\nExclusion Criteria:\n\n* Under the age of 18\n* Patient not undergoing endoscopic treatment for upper gastrointestinal bleeding'}, 'identificationModule': {'nctId': 'NCT04211194', 'briefTitle': 'Registry for Upper Gastrointestinal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'The Orange County Bleeding Consortium (OCBC): Registry of Patients Undergoing Endoscopic Procedures for Upper Gastrointestinal Bleeding in AdventHealth Hospitals in Central Florida', 'orgStudyIdInfo': {'id': '1494617'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with upper gastrointestinal bleeding', 'description': 'Patients with upper gastrointestinal bleeding undergoing endoscopic procedures at AdventHealth Hospitals in Central Florida', 'interventionNames': ['Procedure: Upper GI Endoscopy']}], 'interventions': [{'name': 'Upper GI Endoscopy', 'type': 'PROCEDURE', 'description': 'Patients with upper gastrointestinal bleeding undergoing endoscopic therapy. Information regarding the need for interventional radiology procedures or surgical interventions will also be collected in patients in whom endoscopic therapy is not successful.', 'armGroupLabels': ['Patients with upper gastrointestinal bleeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Interventional Endoscopy', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Shyam Varadarajulu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth Orlando'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}