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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04662918
Enrollment
3000
Registered
2020-12-10
Start date
2022-01-01
Completion date
2025-12-31
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GastroIntestinal Bleeding

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.

Interventions

None listed

Sponsors

Xingshun Qi
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MortalityAn average of 1-6 weeks, from admission to dischargeDeath caused by any events during hospitalizations.

Secondary

MeasureTime frameDescription
Failure to control bleeding within 5 days5 daysFailure 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.

Countries

Brazil, China, Germany, India, Italy, Mexico, Turkey (Türkiye), United States

Contacts

Primary ContactXingshun Qi, Dr.
xingshunqi@126.com18909881019
Backup ContactZhaohui Bai, Dr.
bai_zhao_hui@foxmail.com18524451863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026