The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics

Zhejiang University

Status: Active, not recruiting

Conditions: Cirrhosis; Acute Variceal Haemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT06348004

2024IIT-0125

Details and patient eligibility

About

The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria (1) Patients were diagnosed with liver cirrhosis with esophageal and gastric varices; (2) Patients were presented with any evidence or signs of acute upper gastrointestinal bleeding within 3 days before admission, including hematemesis, melena, and positive fecal occult blood. (3) Endoscopy or imaging data suggested the presence of AVB.

Exclusion criteria

(1) Patients with unstable hemodynamics (patients whose sBP<90mmHg or heart rate >120 bpm at admission). (2) Patients who were initially treated at other facilities but later transferred to our hospital without comprehensive medication records. (3) Ages <18 years old or ages >85 years old. (4) Patients with incomplete data.

Trial design

500 participants in 1 patient group

albumin user group and albumin non-user group