Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-28 @ 10:33 PM
Study NCT ID:
NCT02245802
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2014-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers
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': 785}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-19', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy in prediction of peptic ulcer bleeding related mortality', 'timeFrame': '30 days', 'description': 'The CU prediction score would be calculated from addition of all the risk factors scores. . The calculated predictive score collected from the whole group of patients would be analyzed using the receiver operating characteristic (ROC) curve and represented using the area under curve (AUC). An AUC of 0.5 would be interpreted as poor predictive power whereas a value of 1.0 would indicate excellent predictive power.'}], 'secondaryOutcomes': [{'measure': 'Mortality difference between high risk and low risk group', 'timeFrame': '30 days'}, {'measure': 'Need of Surgery', 'timeFrame': '30 days'}, {'measure': 'Need of Transfusion', 'timeFrame': '30 days', 'description': 'Need of transfusion as represented by number of units transfused'}, {'measure': 'Complication rate', 'timeFrame': '30 days'}, {'measure': 'Hospital stay', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bleeding peptic ulcer', 'Prediction model', 'Mortality', 'Prediction of in-hospital mortality for bleeding peptic ulcer'], 'conditions': ['Bleeding Peptic Ulcer']}, 'referencesModule': {'references': [{'pmid': '18955161', 'type': 'BACKGROUND', 'citation': 'Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K, Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6; quiz 253. doi: 10.1016/j.cgh.2008.08.044. Epub 2008 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.', 'detailedDescription': 'Despite advances in management of patients with bleeding peptic ulcers, mortality is still 10%. We previously reported a prediction score for ulcer bleeding related mortality developed from a local cohort. The risk factors for mortality included patients older than 70, presence of co-morbidity, more than one listed co-morbidity, hematemesis, SBP \\< 100 mmHg, in-hospital bleeding, rebleeding, and need for surgery.\n\nStudy objective This study aimed to validate the prediction of mortality among patients with bleeding peptic ulcers from different Asian countries.\n\nMethod Consecutive patients with bleeding peptic ulcers who presented to the study centers in Hong Kong, Japan and Taiwan were recruited after successful primary endoscopic hemostasis. The baseline demographics, ulcer characteristics, the predictive factors, 30 days mortality, rebleeding, hospital stay and need of surgery were recorded. The accuracy of prediction for adverse events including mortality and rebleeding with the prediction risk scoring system would be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bleeding peptic ulcers who required endoscopic therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients presented with bleeding peptic ulcers\n2. Age \\> 18 year old\n3. Informed consent for the study and OGD\n\nExclusion Criteria:\n\n1. Unable or refuse to give consent\n2. Onset more than 7 days\n3. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02245802', 'briefTitle': 'Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers', 'orgStudyIdInfo': {'id': 'CRE-2010.207'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low risk group', 'description': 'CU Prediction model \\< 3'}, {'label': 'High risk group', 'description': 'CU Prediction model \\>=3'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Hong Kong SAR', 'country': 'China', 'facility': 'Combined Endoscopy Center, Prince of Wales Hospital'}], 'overallOfficials': [{'name': 'Philip Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tokyo University', 'class': 'OTHER'}, {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, {'name': 'Tsuyama Central Hospital, Okayama', 'class': 'UNKNOWN'}, {'name': 'Hiroshima City Asa Hospital, Hiroshima', 'class': 'UNKNOWN'}, {'name': 'Mitoyo General Hospital', 'class': 'UNKNOWN'}, {'name': 'Okayama University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Surgery, Institute of Digestive Disease', 'investigatorFullName': 'Philip Wai Yan Chiu', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}