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

Recruiting

• Conditions: GastroIntestinal Bleeding

• Registration Number: NCT04662918
• Lead Sponsor: Xingshun Qi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Study Start: 2022-01-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	An average of 1-6 weeks, from admission to discharge	Death caused by any events during hospitalizations.

Secondary Outcome Measures

Name	Time	Method
Failure to control bleeding within 5 days	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.

Trial Locations

Locations (23)

Ernakulam Medical Center; 🇮🇳 Kochi, India

The Six People's Hospital of Dalian; 🇨🇳 Dalian, Liaoning, China

Charité University Medical Center; 🇩🇪 Berlin, Germany

National Autonomous University of Mexico; 🇲🇽 Mexico City, Mexico

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The Seventh Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Air Force Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China

The Six People's Hospital of Shenyang; 🇨🇳 Shenyang, Liaoning, China

Tangdu Hospital, Fourth Military Medical University,; 🇨🇳 Xi'an, Shaanxi, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

The Second Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China

Xi'an Central Hospital; 🇨🇳 Xi'an, Shaanxi, China

Cathay General Hospital, Fu-Jen Catholic University School of Medicine; 🇨🇳 Taibei, Taiwan, China

The Wright Center for Graduate Medical Education, 501 S. Washington Avenue; 🇺🇸 Scranton, Pennsylvania, United States

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

Beijing Youan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli; 🇮🇹 Palermo, Italy

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China