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

GastroIntestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662918
• Other study ID #: V-CAGIB 1.0
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: General Hospital of Shenyang Military Region
• Contact: Xingshun Qi, Dr.
• Phone: 18909881019
• Email: xingshunqi[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
Brazil	São Paulo State University (UNESP), Botucatu Medical School	São Paulo
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	The Seventh Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	The Six People's Hospital of Dalian	Dalian	Liaoning
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Shandong Provincial Hospital	Jinan	Shandong
China	First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Air Force Hospital of Northern Theater Command	Shenyang	Liaoning
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Six People's Hospital of Shenyang	Shenyang	Liaoning
China	Cathay General Hospital, Fu-Jen Catholic University School of Medicine	Taibei	Taiwan
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital, Fourth Military Medical University,	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shaanxi
China	Xi'an Central Hospital	Xi'an	Shaanxi
Germany	Charité University Medical Center	Berlin
India	Ernakulam Medical Center	Kochi
Italy	Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli	Palermo
Mexico	National Autonomous University of Mexico	Mexico City
Turkey	Bezmialem Vakif University	Istanbul
United States	The Wright Center for Graduate Medical Education, 501 S. Washington Avenue	Scranton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Xingshun Qi

Countries where clinical trial is conducted

United States,  Brazil,  China,  Germany,  India,  Italy,  Mexico,  Turkey, 

References & Publications (1)

Bai Z, Li B, Lin S, Liu B, Li Y, Zhu Q, Wu Y, Yang Y, Tang S, Meng F, Chen Y, Yuan S, Shao L, Qi X. Development and Validation of CAGIB Score for Evaluating the Prognosis of Cirrhosis with Acute Gastrointestinal Bleeding: A Retrospective Multicenter Study — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death caused by any events during hospitalizations.	An average of 1-6 weeks, from admission to discharge
Secondary	Failure to control bleeding within 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

External Links

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