Evaluating a new scoring system for predicting mortality in cirrhotic patients with gastrointestinal bleeding

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

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
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 23 sites (Scranton, Pennsylvania and 22 other locations)
• Trial ID: NCT04662918 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with liver cirrhosis and acute gastrointestinal bleeding.

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.

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 performed: While the CAGIB score is a novel approach, similar studies using other scoring systems have shown success in predicting outcomes in cirrhotic patients.

Eligibility 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 this trial is running

Scranton, Pennsylvania and 22 other locations

• The Wright Center for Graduate Medical Education, 501 S. Washington Avenue — Scranton, Pennsylvania, United States (Not_yet_recruiting)
• 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)
• The Seventh Medical Center of Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Not_yet_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)
• 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)
• Cathay General Hospital, Fu-Jen Catholic University School of Medicine — Taibei, Taiwan, China (Not_yet_recruiting)
• Charité University Medical Center — Berlin, State of Berlin, Germany (Recruiting)
• Ernakulam Medical Center — Kochi, Kochi, India (Not_yet_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)

Study contacts

• Study coordinator: Xingshun Qi, Dr.

Conditions GastroIntestinal Bleeding