Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding

NCT ID: NCT05613309

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-10-01

Brief Summary

The purpose of this study is to analyze the clinical characteristics of patients with fatal acute variceal bleeding (AVB) and establish a mortality risk prediction model to identify patients at high risk of death after admission, so as to guide clinical practice, further optimize the allocation of emergency resources, and further reduce the mortality of AVB patients.

Detailed Description

How to predict adverse outcomes of acute variceal bleeding and identify high-risk patients remains unclear. Most studies related to risk factors for adverse outcomes in AVB patients took 5 days and 6 weeks as time nodes, and the main outcome indicators were the rebleeding rate and mortality rate at 5 days and 6 weeks. However, some patients admitted to hospital may suffer death within a short period of time ,the investigators will define AVB patients at high risk of death in several hours after admission as fatal acute variceal bleeding.To identify such patients and give more positive treatment can further reduce the mortality of AVB. Such risk stratification can be used to further guide the rational allocation of emergency resources, improve the efficacy of medical resources. This study intends to retrospectively collect the clinical data of AVB patients in Renmin Hospital of Wuhan University, analyze the risk factors for death after admission, establish a mortality risk prediction model, and compare and validate the new model and the scoring model to be verified.

Conditions

Acute Variceal Bleeding

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients with acute varicose hemorrhage in Renmin Hospital of Wuhan University in recent 10 years

In this study, patients with liver cirrhosis and acute variceal bleeding in Renmin Hospital of Wuhan University in the past 10 years will be selected as the research objects. Patients will be divided into survival and death groups according to whether they died 6 hours after admission. The differences in clinical data between the two groups will be compared and analyzed to decide the risk factors for early death and establish a mortality risk prediction model.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. History of cirrhosis/previous history of endoscopic varicose veins/undiagnosed liver disease but signs related to liver disease, hematemesis or melena; The diagnosis of cirrhosis is based on liver biopsy or the usual clinical and radiological criteria;

2. AVB was confirmed by endoscopy without special medical history;

Exclusion Criteria

1. Patients who cannot obtain complete data (vital signs, medical history, laboratory tests and other data are seriously missing);

2. Patients with upper gastrointestinal bleeding have no evidence of AVB.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

ChenMingkai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingkai Chen, PHD

Role: STUDY_DIRECTOR

Renmin Hospital of Wuhan University

Locations

Mingkai Chen

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingkai Chen, PHD

Role: CONTACT

chenmingkai@whu.edu.cn

+8613720330580

Facility Contacts

Mingkai Chen, PHD

Role: primary

chenmingkai@whu.edu.cn

+ 86 13720330580

Other Identifiers

WDRY2022-K204

Identifier Type: -

Identifier Source: org_study_id