Evaluating a new scoring system for predicting mortality in cirrhotic patients with gastrointestinal bleeding
Official title: Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study
Run by General Hospital of Shenyang Military Region · NCT04662918 · Data updated 2026-11-12
This study is testing a new scoring system to see if it can better predict the risk of death in adults with liver cirrhosis who are having gastrointestinal bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 23 sites (Scranton, Pennsylvania and 22 other locations) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT04662918 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with liver cirrhosis and acute gastrointestinal bleeding.
✕Probably not a fit
Patients who do not have available components of the scoring systems or whose in-hospital outcomes cannot be evaluated will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate the CAGIB score, a novel prognostic model, for assessing in-hospital mortality in patients with liver cirrhosis experiencing acute gastrointestinal bleeding. The study will compare the performance of the CAGIB score against established scoring systems, such as Child-Pugh and MELD scores, to determine its effectiveness in predicting patient outcomes. Conducted across multiple international centers, the study will involve adult patients presenting with specific symptoms of gastrointestinal bleeding. The goal is to enhance the accuracy of mortality predictions in this high-risk patient population.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and better management strategies for cirrhotic patients facing acute gastrointestinal bleeding.
How similar studies have gone: While the CAGIB score is a novel approach, similar studies using other scoring systems have shown success in predicting outcomes in cirrhotic patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with liver cirrhosis; 2. Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia; 3. Adults (age≥18 years old). Exclusion Criteria: 1. Components of Child-Pugh, MELD, and CAGIB scores are not available; 2. In-hospital outcomes are not evaluable.
Where it's running
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São Paulo State University (UNESP), Botucatu Medical School
São Paulo, São Paulo, Brazil Recruiting -
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China Recruiting -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China Recruiting -
The Six People's Hospital of Dalian
Dalian, Liaoning, China Recruiting
Show 17 more locations
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Air Force Hospital of Northern Theater Command
Shenyang, Liaoning, China Recruiting -
General Hospital of Northern Theater Command
Shenyang, Liaoning, China Recruiting -
The First Hospital of China Medical University
Shenyang, Liaoning, China Recruiting -
The Six People's Hospital of Shenyang
Shenyang, Liaoning, China Recruiting -
Tangdu Hospital, Fourth Military Medical University,
Xi'an, Shaanxi, China Recruiting -
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China Recruiting -
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China Recruiting -
Xi'an Central Hospital
Xi'an, Shaanxi, China Recruiting -
Shandong Provincial Hospital
Jinan, Shandong, China Recruiting -
Charité University Medical Center
Berlin, State of Berlin, Germany Recruiting -
Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
Palermo, Palermo, Italy Recruiting -
National Autonomous University of Mexico
Mexico City, Mexico City, Mexico Recruiting -
Bezmialem Vakif University
Istanbul, Istanbul, Turkey (Türkiye) Recruiting -
The Wright Center for Graduate Medical Education, 501 S. Washington Avenue
Scranton, Pennsylvania, United States Not yet recruiting -
The Seventh Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China Not yet recruiting -
Cathay General Hospital, Fu-Jen Catholic University School of Medicine
Taibei, Taiwan, China Not yet recruiting -
Ernakulam Medical Center
Kochi, Kochi, India Not yet recruiting
Study contacts
- Study coordinator: Xingshun Qi, Dr.
- Email: xingshunqi@126.com
- Phone: 18909881019
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Endovascular treatment outcomes after portal hypertension–related GI bleeding in cirrhosis
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-
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This project will see how doctors treat gastrointestinal bleeding in adults on direct oral anticoagulants and whether giving prothrombin complex concentrate (PCC) appears helpful and safe.
-
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This trial will test a swallowed wireless optical capsule (HemoPill) to see if it can detect bleeding in adults with suspected upper gastrointestinal bleeding.
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Using physiological parameters to predict outcomes in cirrhotic patients with gastrointestinal bleeding
This study is testing if certain health measurements can help doctors predict how well patients with liver cirrhosis and gastrointestinal bleeding will do, so they can provide better emergency care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.