GastroIntestinal BleedingNCT04662918
Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding
An observational study of GastroIntestinal Bleeding, run by Xingshun Qi at 23 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GastroIntestinal Bleeding
- How many people
- 3,000 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 1 Jan 2022to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis and acute gastrointestinal bleeding
Who may be able to join
- Patients with liver cirrhosis;
- Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia;
- Adults (age≥18 years old).
Who cannot join
- Components of Child-Pugh, MELD, and CAGIB scores are not available;
- In-hospital outcomes are not evaluable.
Trial locations and contacts
23 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 8 countries
China16 sites, 16 recruiting
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Yu Chen, Dr., chybeyond@163.com
- Not yet recruiting
The Seventh Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality
Juqiang Han, Dr., hanjuqiang2014@126.com
- Recruiting
The Six People's Hospital of Dalian
Dalian, Liaoning
Dapeng Ma, Dr., dllymdp@126.com
- Recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Su Lin, Dr., sumer5129@163.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Qiang Zhu, Dr., zhuqiang@medmail.com.cn
- Recruiting
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Bimin Li, Dr., lbmjx@163.com
- Recruiting
Air Force Hospital of Northern Theater Command
Shenyang, Liaoning
Lichun Shao, Dr., slc700214@163.com
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Xingshun Qi, Dr., xingshunqi@126.com
Zhaohui Bai, Dr., bai_zhao_hui@foxmail.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Yiling Li, Dr., lyl-72@163.com
- Recruiting
The Six People's Hospital of Shenyang
Shenyang, Liaoning
Yunhai Wu, Dr., wyhai007@163.com
- Not yet recruiting
Cathay General Hospital, Fu-Jen Catholic University School of Medicine
Taibei, Taiwan
Rei-Ting Hu, Dr., huyeh0203@gmail.com
Sien-Sing Yang, Dr., yangsien@hotmail.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Ling Yang, Dr., hepayang@163.com
- Recruiting
Tangdu Hospital, Fourth Military Medical University,
Xi'an, Shaanxi
Lei Liu, Dr., liulei84207@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi
Yingli He, Dr., heyingli2000@163.com
- Recruiting
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi
Fanpu Ji, Dr., jifanpu1979@163.com
- Recruiting
Xi'an Central Hospital
Xi'an, Shaanxi
Shanshan Yuan, Dr., shanshanyuan007@163.com
United States1 site, 1 recruiting
- Not yet recruiting
The Wright Center for Graduate Medical Education, 501 S. Washington Avenue
Scranton, Pennsylvania, 18503
Hemant Goyal, Dr., doc.hemant@yahoo.com
Brazil1 site, 1 recruiting
- Recruiting
São Paulo State University (UNESP), Botucatu Medical School
São Paulo, São Paulo
Fernando Gomes Romeiro, Dr, fgromeiro@gmail.com
Germany1 site, 1 recruiting
- Recruiting
Charité University Medical Center
Berlin, State of Berlin
Frank Tacke, Dr., frank.tacke@gmx.net
Cornelius Engelmann, cornelius.engelmann@charite.de
India1 site, 1 recruiting
- Not yet recruiting
Ernakulam Medical Center
Kochi, Kochi
Cyriac Abby Philips, Dr, abbyphilips@gmail.com
Italy1 site, 1 recruiting
- Recruiting
Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
Palermo, Palermo
Andrea Mancuso, Dr, mancandrea@libero.it
Mexico1 site, 1 recruiting
- Recruiting
National Autonomous University of Mexico
Mexico City, Mexico City
Nahum Méndez-Sánchez, Dr, nah@unam.mx
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Istanbul
Metin Basaranoglu, Dr, metin_basaranoglu@yahoo.com
About this study
Official title: Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study
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.
- Conditions
- GastroIntestinal Bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death caused by any events during hospitalizations.
Measured: An average of 1-6 weeks, from admission to discharge
Secondary outcomes (1)
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroIntestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xingshun Qi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingshun Qi, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662918
- Sponsor's protocol ID
- V-CAGIB 1.0
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2020
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31512140Marcondes MB, Moreno CF, Suzuki CMP, Rodrigues MAG, Moreira A, Qi X, Romeiro FG. Impact of Cirrhosis Etiology and Intensive Care Accessibility on Upper Gastrointestinal Bleeding: A Prospective Observational Study. Can J Gastroenterol Hepatol. 2026;2026(1):e1409025. doi: 10.1155/cjgh/1409025.
PubMed 42216795Zhang S, Sun M, Yuan S, Lin S, Romeiro FG, He Y, Zhu Q, Ma D, Li Y, Philips CA, Liu X, Mendez-Sanchez N, Shao L, Wu Y, Basaranoglu M, Pinyopornpanish K, Chen Y, Mancuso A, Yang L, Tacke F, Li B, Liu L, Ji F, Qi X. Identifying Low-Risk Patients with Cirrhosis and Acute Gastrointestinal Bleeding That May Not Require Urgent Endoscopy. Adv Ther. 2026 Jan;43(1):288-303. doi: 10.1007/s12325-025-03395-1. Epub 2025 Nov 22.
PubMed 41273618Bai 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.
PubMed 40745090
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT04662918
- Acronym / sponsor ID
- V-CAGIB 1.0
- Conditions
- GastroIntestinal Bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xingshun QiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis and acute gastrointestinal bleeding
Key inclusion criteria (3 listed)
- Patients with liver cirrhosis;
- Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia;
- Adults (age≥18 years old).
Key exclusion criteria (2 listed)
- Components of Child-Pugh, MELD, and CAGIB scores are not available;
- In-hospital outcomes are not evaluable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: An average of 1-6 weeks, from admission to discharge
Death caused by any events during hospitalizations.
1 secondary outcome
Failure to control bleeding within 5 days
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 31512140Bai 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.
- Derived from this study: PubMed 42216795Marcondes MB, Moreno CF, Suzuki CMP, Rodrigues MAG, Moreira A, Qi X, Romeiro FG. Impact of Cirrhosis Etiology and Intensive Care Accessibility on Upper Gastrointestinal Bleeding: A Prospective Observational Study. Can J Gastroenterol Hepatol. 2026;2026(1):e1409025. doi: 10.1155/cjgh/1409025.
- Derived from this study: PubMed 41273618Zhang S, Sun M, Yuan S, Lin S, Romeiro FG, He Y, Zhu Q, Ma D, Li Y, Philips CA, Liu X, Mendez-Sanchez N, Shao L, Wu Y, Basaranoglu M, Pinyopornpanish K, Chen Y, Mancuso A, Yang L, Tacke F, Li B, Liu L, Ji F, Qi X. Identifying Low-Risk Patients with Cirrhosis and Acute Gastrointestinal Bleeding That May Not Require Urgent Endoscopy. Adv Ther. 2026 Jan;43(1):288-303. doi: 10.1007/s12325-025-03395-1. Epub 2025 Nov 22.
- Derived from this study: PubMed 40745090Bai 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for GastroIntestinal Bleeding
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GastroIntestinal Bleeding, run by Xingshun Qi at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China, United States, Brazil, Germany, India and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingshun Qi, Dr. (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: An average of 1-6 weeks, from admission to discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662918, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.