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

NCT ID: NCT04662918

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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GastroIntestinal Bleeding

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xingshun Qi

OTHER

Sponsor Role lead

Responsible Party

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Xingshun Qi

Dr., Associate Professor, Vice-Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Wright Center for Graduate Medical Education, 501 S. Washington Avenue

Scranton, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

São Paulo State University (UNESP), Botucatu Medical School

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

The Seventh Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The Six People's Hospital of Dalian

Dalian, Liaoning, China

Site Status RECRUITING

Air Force Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

The Six People's Hospital of Shenyang

Shenyang, Liaoning, China

Site Status RECRUITING

Tangdu Hospital, Fourth Military Medical University,

Xi'an, Shaanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Site Status RECRUITING

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Xi'an Central Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

Cathay General Hospital, Fu-Jen Catholic University School of Medicine

Taibei, Taiwan, China

Site Status NOT_YET_RECRUITING

Charité University Medical Center

Berlin, State of Berlin, Germany

Site Status RECRUITING

Ernakulam Medical Center

Kochi, Kochi, India

Site Status NOT_YET_RECRUITING

Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli

Palermo, Palermo, Italy

Site Status RECRUITING

National Autonomous University of Mexico

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Bezmialem Vakif University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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

Central Contacts

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Xingshun Qi, Dr.

Role: CONTACT

18909881019

Zhaohui Bai, Dr.

Role: CONTACT

18524451863

Facility Contacts

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Hemant Goyal, Dr.

Role: primary

Fernando Gomes Romeiro, Dr

Role: primary

Yu Chen, Dr.

Role: primary

Juqiang Han, Dr.

Role: primary

Su Lin, Dr.

Role: primary

Ling Yang, Dr.

Role: primary

Bimin Li, Dr.

Role: primary

Dapeng Ma, Dr.

Role: primary

Lichun Shao, Dr.

Role: primary

Xingshun Qi, Dr.

Role: primary

Zhaohui Bai, Dr.

Role: backup

Yiling Li, Dr.

Role: primary

Yunhai Wu, Dr.

Role: primary

Lei Liu, Dr.

Role: primary

Yingli He, Dr.

Role: primary

Fanpu Ji, Dr.

Role: primary

Shanshan Yuan, Dr.

Role: primary

Qiang Zhu, Dr.

Role: primary

Rei-Ting Hu, Dr.

Role: primary

Sien-Sing Yang, Dr.

Role: backup

Frank Tacke, Dr.

Role: primary

Cornelius Engelmann

Role: backup

Cyriac Abby Philips, Dr

Role: primary

Andrea Mancuso, Dr

Role: primary

Nahum Méndez-Sánchez, Dr

Role: primary

Metin Basaranoglu, Dr

Role: primary

References

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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.

Reference Type RESULT
PMID: 31512140 (View on PubMed)

Bai Z, Lin S, Sun M, Yuan S, Marcondes MB, Ma D, Zhu Q, Li Y, He Y, Philips CA, Liu X, Pinyopornpanish K, Shao L, Mendez-Sanchez N, Basaranoglu M, Wu Y, Chen Y, Yang L, Mancuso A, Tacke F, Li B, Liu L, Ji F, Qi X. Machine learning based CAGIB score predicts in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding. NPJ Digit Med. 2025 Jul 31;8(1):489. doi: 10.1038/s41746-025-01883-w.

Reference Type DERIVED
PMID: 40745090 (View on PubMed)

Related Links

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Other Identifiers

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V-CAGIB 1.0

Identifier Type: -

Identifier Source: org_study_id

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