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

Wuhan University

Status: Enrolling

Conditions: Acute Variceal Bleeding

Study type: Observational

Funder types: Other

Identifiers

NCT05613309

WDRY2022-K204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

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

Description:

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.