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

Acute Variceal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613309
• Other study ID #: WDRY2022-K204
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: Renmin Hospital of Wuhan University
• Contact: Mingkai Chen, PHD
• Phone: +8613720330580
• Email: chenmingkai[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Variceal Bleeding
• Hemorrhage

Locations

Country	Name	City	State
China	Mingkai Chen	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute death occurred 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)	Six hours after admission