Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT05646433
Status:
UNKNOWN
Last Update Posted:
2023-07-06
First Post:
2022-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score
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', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2022-12-03', 'studyFirstSubmitQcDate': '2022-12-03', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was all-cause in-hospital mortality rate', 'timeFrame': '30 days after inclusion', 'description': 'The primary outcome was all-cause in-hospital mortality rate'}], 'secondaryOutcomes': [{'measure': 're-bleeding, re-hospitalization, discharge', 'timeFrame': '30 days after inclusion', 'description': 'Hemorrhagic recurrence is defined by recurrence of hematemesis, melena or rectal bleeding after discharge from hospital within 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper Gastro intestinal bleeding; TU-GIB score; ED'], 'conditions': ['Gastro Intestinal Bleed']}, 'descriptionModule': {'briefSummary': 'We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.\n\nThis score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.\n\nIn a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.', 'detailedDescription': 'We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.\n\nThis score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.\n\nIn a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.\n\nWe will conduct a multicenter, descriptive and analytical study in different emergency departments Inclusion criteria: patients consulting the emergency department for upper GI hemorrhage of non-traumatic origin.\n\nExclusion criteria: patients under 18 years of age, diagnosed with external hemorrhoids with parietal lesions. We exclude any patient who does not consent, is lost to follow-up or has incomplete information.\n\nAnonymity and confidentiality of the data were respected. Data collection was carried out using a data processing form designed for the purpose of this work, including descriptive analysis of the epidemiological and clinical characteristics of the patients, as well as the para-clinical data.\n\nPatients were followed up by telephone call at D30 to record the date and cause of any complications noted, such as rebleeding, hospitalization, or death.\n\nThe data will be entered and analyzed in SPSS 21.0'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'multicentric, descriptive and analytical study in different emergency departments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients consulting the emergency room for upper GI hemorrhage of non-traumatic origin.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* patient under the age of 18\n* Lower gastrointestinal hemorrhag\n* diagnosis of external hemorrhoids / perianal lesions\n* Not consenting\n* The lost sight'}, 'identificationModule': {'nctId': 'NCT05646433', 'acronym': 'TU-GIBscore', 'briefTitle': 'Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Universitaire Sahloul'}, 'officialTitle': 'Validation of a New Tunisian Risk Score for Upper Gastrointestinal Bleeding in the Emergency Room: Study of the TU-GIB Score', 'orgStudyIdInfo': {'id': 'TU-GIBscore'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Sousse', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'riadh boukef, professor', 'role': 'CONTACT', 'email': 'riadboukef@gmail.com', 'phone': '98676745', 'phoneExt': '216'}], 'facility': 'Sahloul University Hospital', 'geoPoint': {'lat': 35.82539, 'lon': 10.63699}}], 'centralContacts': [{'name': 'Riadh Boukef, professor', 'role': 'CONTACT', 'email': 'riadboukef@gmail.com', 'phone': '0021698676745'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Universitaire Sahloul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Riadh Boukef', 'investigatorAffiliation': 'Hôpital Universitaire Sahloul'}}}}