Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding

October 2, 2025 updated by: Xingshun Qi

Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil
        • Recruiting
        • São Paulo State University (UNESP), Botucatu Medical School
        • Contact:
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • The Seventh Medical Center of Chinese PLA General Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • First Affiliated Hospital of Nanchang University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The Six People's Hospital of Dalian
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China
      • Shenyang, Liaoning, China
        • Recruiting
        • Air Force Hospital of Northern Theater Command
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • The Six People's Hospital of Shenyang
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China
      • Xi'an, Shaanxi, China
        • Recruiting
        • Tangdu Hospital, Fourth Military Medical University,
        • Contact:
      • Xi'an, Shaanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
      • Xi'an, Shaanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
    • Shandong
      • Jinan, Shandong, China
    • Taiwan
      • Taibei, Taiwan, China
        • Not yet recruiting
        • Cathay General Hospital, Fu-Jen Catholic University School of Medicine
        • Contact:
        • Contact:
  • Germany
  • India
    • Kochi
      • Kochi, Kochi, India
        • Not yet recruiting
        • Ernakulam Medical Center
        • Contact:
  • Italy
    • Palermo
      • Palermo, Palermo, Italy
        • Recruiting
        • Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
        • Contact:
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico
        • Recruiting
        • National Autonomous University of Mexico
        • Contact:
  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
  • United States
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18503
        • Not yet recruiting
        • The Wright Center for Graduate Medical Education, 501 S. Washington Avenue
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with liver cirrhosis and acute gastrointestinal bleeding

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: An average of 1-6 weeks, from admission to discharge
Death caused by any events during hospitalizations.
An average of 1-6 weeks, from admission to discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure to control bleeding within 5 days
Time Frame: 5 days
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.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xingshun Qi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V-CAGIB 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on GastroIntestinal Bleeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe