Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-24 @ 7:45 AM
Study NCT ID:
NCT02152904
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2014-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 892}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rebleeding rate of peptic ulcer bleeding', 'timeFrame': '1 year', 'description': 'The rebleeding rate of patients diagnosed with peptic ulcer ble4eding'}], 'secondaryOutcomes': [{'measure': 'Mortality rates of peptic ulcer bleeding', 'timeFrame': '30 days', 'description': 'The 30 day mortality rate of patients diagnosed with peptic ulcer bleeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peptic ulcer bleeding', 'rebleeding', 'mortality', 'nationwide'], 'conditions': ['Peptic Ulcer Bleeding']}, 'descriptionModule': {'briefSummary': 'The purpose of the investigators study is to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding.', 'detailedDescription': 'The investigators are performing a nationwide population based cohort study to investigate the factors associated with rebleeding in patients with peptic ulcer bleeding. The results of the investigators study should give us information about patients who are at high risk of rebleeindg and enable us to manage these patients appropriately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who visit the hospital with symptoms suggestive of peptic ulcer bleeding such as melena or hematemesis. These patients recieve endoscopy and when they are diagnosed with peptic ulcer bleeding are eligible for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with peptic ulcer bleeding by endoscopy\n* Patients who consent to be enrolled in the study\n\nExclusion Criteria:\n\n* Patients who refuse to be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT02152904', 'acronym': 'KPUB', 'briefTitle': 'Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study', 'organization': {'class': 'OTHER', 'fullName': "Incheon St.Mary's Hospital"}, 'officialTitle': 'Risk Factors of Rebleeding After Peptic Ulcer Bleeding: a Nationwide Cohort Study', 'orgStudyIdInfo': {'id': 'KPUB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peptic ulcer bleeding patients', 'description': 'Endoscopy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': "Incheon St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Byung-Wook Kim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Incheon St. Mary's Hospital, The Catholic University of Korea"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joon Sung Kim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Clinical assistant proffessor, Department of Internal medicine, Incheon St. Mary's Hospital", 'investigatorFullName': 'Joon Sung Kim', 'investigatorAffiliation': "Incheon St.Mary's Hospital"}}}}