Clinical trial Recruiting at 19 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment3000 (estimated)
SponsorGeneral Hospital of Shenyang Military Region
Academic / other
Locations23 sites (Scranton, Pennsylvania and 22 other locations)
StatusRecruiting
StartedJanuary 1, 2022
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedOctober 7, 2025
Trial IDNCT04662918 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.