Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 9:47 PM
Study NCT ID:
NCT01589250
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Scoring Systems in Upper GI-haemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 831}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2012-04-30', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for hospital-based intervention', 'timeFrame': '1 month', 'description': 'Need of hospital-based intervention was defined as treatment with blood transfusion, endoscopic therapy, transcatheter arterial embolization (TAE), surgery, or identification of cancer at upper endoscopy.'}], 'secondaryOutcomes': [{'measure': 'Identification of low-risk patients', 'timeFrame': '1 month', 'description': 'Low-risk patients were defined as patients who did not need hospital-based intervention, and survived more than 30 days from day of admission. Low-risk patients were considered as suitable for early discharge and potential outpatient management.'}, {'measure': 'Rebleeding', 'timeFrame': '1 month', 'description': 'Rebleeding was defined as presence of hematemesis, blood per nasogastric tube, or melaena associated with a decline in B-hemoglobin of at least 1mmol/l (not explained by hemodilution) or decline in systolic arterial pressure of at least 20mmHg after the initial bleeding had stopped.'}, {'measure': '30 day mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Upper Gastrointestinal Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '22801061', 'type': 'DERIVED', 'citation': 'Laursen SB, Hansen JM, Schaffalitzky de Muckadell OB. The Glasgow Blatchford score is the most accurate assessment of patients with upper gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1130-1135.e1. doi: 10.1016/j.cgh.2012.06.022. Epub 2012 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'Use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was to identify the optimal scoring system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data were collected from consecutive patients admitted with UGIH at Odense University Hospital between August 2009 and August 2011. UGIH was defined as history of haematemesis, coffee-ground vomit, or melaena.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOne of the following:\n\n* Haematemesis\n* Melaena\n* Coffee-ground vomit'}, 'identificationModule': {'nctId': 'NCT01589250', 'briefTitle': 'Risk Scoring Systems in Upper GI-haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Risk Scoring Systems in Upper GI-haemorrhage', 'orgStudyIdInfo': {'id': 'SBL-03'}}, 'contactsLocationsModule': {'locations': [{'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Stig Borbjerg Laursen', 'investigatorAffiliation': 'Odense University Hospital'}}}}