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

NCT05613309 | Unknown

• 1 other identifier: WDRY2022-K204
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Variceal Bleeding

Keywords

Acute variceal bleeding; Mortality risk prediction model

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Mingkai Chen

Wuhan, Hubei, 430060, China

RECRUITING

Study Officials

• Mingkai Chen, PHD

  Renmin Hospital of Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Mingkai Chen, PHD

CONTACT

+8613720330580; chenmingkai@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

CN (1)