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

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ClinicalTrials.gov Identifier: NCT04662918
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Xingshun Qi, General Hospital of Shenyang Military Region

Study Description
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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.

Condition or disease
GastroIntestinal Bleeding

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: An average of 1-6 weeks, from admission to discharge ]
    Death caused by any events during hospitalizations.


Secondary Outcome Measures :
  1. Failure to control bleeding within 5 days [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with liver cirrhosis and acute gastrointestinal bleeding
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662918


Contacts
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Contact: Xingshun Qi, Dr. 18909881019 xingshunqi@126.com
Contact: Zhaohui Bai, Dr. 18524451863 bai_zhao_hui@foxmail.com

Locations
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Sponsors and Collaborators
Xingshun Qi
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Xingshun Qi, Dr., Associate Professor, Vice-Chief Physician, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT04662918    
Other Study ID Numbers: V-CAGIB 1.0
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases