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

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.

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Key information

Conditions

Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

São Paulo State University (UNESP), Botucatu Medical School, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with liver cirrhosis;
Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia;
Adults (age≥18 years old).

Exclusion criteria

Components of Child-Pugh, MELD, and CAGIB scores are not available;
In-hospital outcomes are not evaluable.

Treatment and study plan

Primary outcomes

Mortality

Time frame: An average of 1-6 weeks, from admission to discharge

Death caused by any events during hospitalizations.

Secondary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xingshun Qi, Dr.

CONTACT

[email protected]

18909881019

Zhaohui Bai, Dr.

CONTACT

[email protected]

18524451863

Sponsors and collaborators

Lead sponsor

Xingshun Qi

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 10, 2020
Registry last updated: Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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