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Clinical Trials/NCT05613309
NCT05613309
Recruiting
Not Applicable

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

Renmin Hospital of Wuhan University1 site in 1 country3,000 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Variceal Bleeding
Sponsor
Renmin Hospital of Wuhan University
Enrollment
3000
Locations
1
Primary Endpoint
Acute death occurred after admission
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
October 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ChenMingkai

Professor

Renmin Hospital of Wuhan University

Eligibility Criteria

Inclusion Criteria

  • 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;
  • AVB was confirmed by endoscopy without special medical history;

Exclusion Criteria

  • Patients who cannot obtain complete data (vital signs, medical history, laboratory tests and other data are seriously missing);
  • Patients with upper gastrointestinal bleeding have no evidence of AVB.

Outcomes

Primary Outcomes

Acute death occurred after admission

Time Frame: Six hours after admission

Death in patients with acute varicose bleeding in cirrhosis occurs within a short time (initially defined as less than 6 hours after admission)

Study Sites (1)

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