Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04662918
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, '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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'An average of 1-6 weeks, from admission to discharge', 'description': 'Death caused by any events during hospitalizations.'}], 'secondaryOutcomes': [{'measure': 'Failure to control bleeding within 5 days', 'timeFrame': '5 days', 'description': 'Failure is defined as death or need to change therapy defined by one of the following criteria within 5 days: 1) Fresh hematemesis or nasogastric aspiration of ≥100 ml of fresh blood ≥2 h after the start of a specific drug treatment or therapeutic endoscopy; 2) Development of hypovolaemic shock; 3) 3g drop in hemoglobin (9% drop of hematocrit) within any 24 hours period if no transfusion is administered.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GastroIntestinal Bleeding']}, 'referencesModule': {'references': [{'pmid': '31512140', 'type': 'RESULT', 'citation': 'Bai Z, Li B, Lin S, Liu B, Li Y, Zhu Q, Wu Y, Yang Y, Tang S, Meng F, Chen Y, Yuan S, Shao L, Qi X. Development and Validation of CAGIB Score for Evaluating the Prognosis of Cirrhosis with Acute Gastrointestinal Bleeding: A Retrospective Multicenter Study. Adv Ther. 2019 Nov;36(11):3211-3220. doi: 10.1007/s12325-019-01083-5. Epub 2019 Sep 11.'}, {'pmid': '41273618', 'type': 'DERIVED', 'citation': 'Zhang S, Sun M, Yuan S, Lin S, Romeiro FG, He Y, Zhu Q, Ma D, Li Y, Philips CA, Liu X, Mendez-Sanchez N, Shao L, Wu Y, Basaranoglu M, Pinyopornpanish K, Chen Y, Mancuso A, Yang L, Tacke F, Li B, Liu L, Ji F, Qi X. Identifying Low-Risk Patients with Cirrhosis and Acute Gastrointestinal Bleeding That May Not Require Urgent Endoscopy. Adv Ther. 2025 Nov 22. doi: 10.1007/s12325-025-03395-1. Online ahead of print.'}, {'pmid': '40745090', 'type': 'DERIVED', 'citation': 'Bai Z, Lin S, Sun M, Yuan S, Marcondes MB, Ma D, Zhu Q, Li Y, He Y, Philips CA, Liu X, Pinyopornpanish K, Shao L, Mendez-Sanchez N, Basaranoglu M, Wu Y, Chen Y, Yang L, Mancuso A, Tacke F, Li B, Liu L, Ji F, Qi X. Machine learning based CAGIB score predicts in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding. NPJ Digit Med. 2025 Jul 31;8(1):489. doi: 10.1038/s41746-025-01883-w.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31512140/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Acute gastrointestinal bleeding is potentially lethal in liver cirrhosis. Accurate assessment of prognosis is critical in a timely fashion. A novel model, CAGIB score, has been developed based on our Chinese multicenter retrospective study. Now, a prospective, international multicenter, observational study will be performed to further compare the performance of CAGIB versus Child-Pugh and MELD scores for evaluating the in-hospital mortality of patients with liver cirrhosis and acute gastrointestinal bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver cirrhosis and acute gastrointestinal bleeding', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with liver cirrhosis;\n2. Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia;\n3. Adults (age≥18 years old).\n\nExclusion Criteria:\n\n1. Components of Child-Pugh, MELD, and CAGIB scores are not available;\n2. In-hospital outcomes are not evaluable.'}, 'identificationModule': {'nctId': 'NCT04662918', 'briefTitle': 'Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study', 'orgStudyIdInfo': {'id': 'V-CAGIB 1.0'}}, 'contactsLocationsModule': {'locations': [{'zip': '18503', 'city': 'Scranton', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hemant Goyal, Dr.', 'role': 'CONTACT', 'email': 'doc.hemant@yahoo.com'}], 'facility': 'The Wright Center for Graduate Medical Education, 501 S. Washington Avenue', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}, {'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Fernando Gomes Romeiro, Dr', 'role': 'CONTACT', 'email': 'fgromeiro@gmail.com'}], 'facility': 'São Paulo State University (UNESP), Botucatu Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Chen, Dr.', 'role': 'CONTACT', 'email': 'chybeyond@163.com'}], 'facility': 'Beijing Youan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juqiang Han, Dr.', 'role': 'CONTACT', 'email': 'hanjuqiang2014@126.com'}], 'facility': 'The Seventh Medical Center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Su Lin, Dr.', 'role': 'CONTACT', 'email': 'sumer5129@163.com'}], 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Yang, Dr.', 'role': 'CONTACT', 'email': 'hepayang@163.com'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bimin Li, Dr.', 'role': 'CONTACT', 'email': 'lbmjx@163.com'}], 'facility': 'First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dapeng Ma, Dr.', 'role': 'CONTACT', 'email': 'dllymdp@126.com'}], 'facility': "The Six People's Hospital of Dalian", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lichun Shao, Dr.', 'role': 'CONTACT', 'email': 'slc700214@163.com'}], 'facility': 'Air Force Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingshun Qi, Dr.', 'role': 'CONTACT', 'email': 'xingshunqi@126.com'}, {'name': 'Zhaohui Bai, Dr.', 'role': 'CONTACT', 'email': 'bai_zhao_hui@foxmail.com'}], 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiling Li, Dr.', 'role': 'CONTACT', 'email': 'lyl-72@163.com'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunhai Wu, Dr.', 'role': 'CONTACT', 'email': 'wyhai007@163.com'}], 'facility': "The Six People's Hospital of Shenyang", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Liu, Dr.', 'role': 'CONTACT', 'email': 'liulei84207@163.com'}], 'facility': 'Tangdu Hospital, Fourth Military Medical University,', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingli He, Dr.', 'role': 'CONTACT', 'email': 'heyingli2000@163.com'}], 'facility': "The First Affiliated Hospital of Xi'an Jiao Tong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fanpu Ji, Dr.', 'role': 'CONTACT', 'email': 'jifanpu1979@163.com'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiao Tong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanshan Yuan, Dr.', 'role': 'CONTACT', 'email': 'shanshanyuan007@163.com'}], 'facility': "Xi'an Central Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Zhu, Dr.', 'role': 'CONTACT', 'email': 'zhuqiang@medmail.com.cn'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Taibei', 'state': 'Taiwan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rei-Ting Hu, Dr.', 'role': 'CONTACT', 'email': 'huyeh0203@gmail.com'}, {'name': 'Sien-Sing Yang, Dr.', 'role': 'CONTACT', 'email': 'yangsien@hotmail.com'}], 'facility': 'Cathay General Hospital, Fu-Jen Catholic University School of Medicine', 'geoPoint': {'lat': 34.7, 'lon': 119.23333}}, {'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frank Tacke, Dr.', 'role': 'CONTACT', 'email': 'frank.tacke@gmx.net'}, {'name': 'Cornelius Engelmann', 'role': 'CONTACT', 'email': 'cornelius.engelmann@charite.de'}], 'facility': 'Charité University Medical Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Kochi', 'state': 'Kochi', 'status': 'NOT_YET_RECRUITING', 'country': 'India', 'contacts': [{'name': 'Cyriac Abby Philips, Dr', 'role': 'CONTACT', 'email': 'abbyphilips@gmail.com'}], 'facility': 'Ernakulam Medical Center', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'city': 'Palermo', 'state': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Mancuso, Dr', 'role': 'CONTACT', 'email': 'mancandrea@libero.it'}], 'facility': 'Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Nahum Méndez-Sánchez, Dr', 'role': 'CONTACT', 'email': 'nah@unam.mx'}], 'facility': 'National Autonomous University of Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Metin Basaranoglu, Dr', 'role': 'CONTACT', 'email': 'metin_basaranoglu@yahoo.com'}], 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Xingshun Qi, Dr.', 'role': 'CONTACT', 'email': 'xingshunqi@126.com', 'phone': '18909881019'}, {'name': 'Zhaohui Bai, Dr.', 'role': 'CONTACT', 'email': 'bai_zhao_hui@foxmail.com', 'phone': '18524451863'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xingshun Qi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr., Associate Professor, Vice-Chief Physician', 'investigatorFullName': 'Xingshun Qi', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}