Clinical trial NCT04662918: Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding
Official title: Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GastroIntestinal Bleeding
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis and acute 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.


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.

Primary outcomes:
measure: Mortality
timeFrame: An average of 1-6 weeks, from admission to discharge
Secondary outcomes:
measure: Failure to control bleeding within 5 days
timeFrame: 5 days
Other outcomes:
Locations:
city: Scranton
country: United States
facility: The Wright Center for Graduate Medical Education, 501 S. Washington Avenue
state: Pennsylvania
city: São Paulo
country: Brazil
facility: São Paulo State University (UNESP), Botucatu Medical School
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: The Seventh Medical Center of Chinese PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: The Six People's Hospital of Dalian
state: Liaoning
city: Shenyang
country: China
facility: Air Force Hospital of Northern Theater Command
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Six People's Hospital of Shenyang
state: Liaoning
city: Xi'an
country: China
facility: Tangdu Hospital, Fourth Military Medical University,
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Taibei
country: China
facility: Cathay General Hospital, Fu-Jen Catholic University School of Medicine
state: Taiwan
city: Berlin
country: Germany
facility: Charité University Medical Center
city: Kochi
country: India
facility: Ernakulam Medical Center
city: Palermo
country: Italy
facility: Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
city: Mexico City
country: Mexico
facility: National Autonomous University of Mexico
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
citation: 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. Adv Ther. 2019 Nov;36(11):3211-3220. doi: 10.1007/s12325-019-01083-5. Epub 2019 Sep 11.