Clinical trial NCT05613309: Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding
Official title: Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Variceal Bleeding
Keywords: Acute variceal bleeding
Mortality risk prediction model
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute varicose hemorrhage in Renmin Hospital of Wuhan University in recent 10 years

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute death occurred after admission
timeFrame: Six hours after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Mingkai Chen
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, PHD
role: STUDY_DIRECTOR
References: