Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding
1 other identifier
observational
3,000
8 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 7, 2025
October 1, 2025
3.9 years
December 2, 2020
October 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
Death caused by any events during hospitalizations.
An average of 1-6 weeks, from admission to discharge
Secondary Outcomes (1)
Failure to control bleeding within 5 days
5 days
Eligibility Criteria
Patients with liver cirrhosis and acute gastrointestinal bleeding
You may qualify if:
- Patients with liver cirrhosis;
- Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia;
- Adults (age≥18 years old).
You may not qualify if:
- Components of Child-Pugh, MELD, and CAGIB scores are not available;
- In-hospital outcomes are not evaluable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xingshun Qilead
Study Sites (23)
The Wright Center for Graduate Medical Education, 501 S. Washington Avenue
Scranton, Pennsylvania, 18503, United States
São Paulo State University (UNESP), Botucatu Medical School
São Paulo, São Paulo, Brazil
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Seventh Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Six People's Hospital of Dalian
Dalian, Liaoning, China
Air Force Hospital of Northern Theater Command
Shenyang, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Six People's Hospital of Shenyang
Shenyang, Liaoning, China
Tangdu Hospital, Fourth Military Medical University,
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Xi'an Central Hospital
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Cathay General Hospital, Fu-Jen Catholic University School of Medicine
Taibei, Taiwan, China
Charité University Medical Center
Berlin, State of Berlin, Germany
Ernakulam Medical Center
Kochi, Kochi, India
Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
Palermo, Palermo, Italy
National Autonomous University of Mexico
Mexico City, Mexico City, Mexico
Bezmialem Vakif University
Istanbul, Istanbul, Turkey (Türkiye)
Related Publications (3)
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: 31512140RESULTZhang 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: 41273618DERIVEDBai 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.
PMID: 40745090DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr., Associate Professor, Vice-Chief Physician
Study Record Dates
First Submitted
December 2, 2020
First Posted
December 10, 2020
Study Start
January 1, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share