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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Variceal Bleeding

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Mingkai Chen, PHD; Phone Number: +8613720330580; Email: chenmingkai@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Mingkai Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Investigators: Study Director: Mingkai Chen, PHD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Acute variceal bleeding; Mortality risk prediction model
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: WDRY2022-K204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No