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

NCT06348004 | Active Not Recruiting

• 1 other identifier: 2024IIT-0125
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Acute Variceal Haemorrhage

Outcome Measures

Primary Outcomes (1)

• The rebleeding risk within 30 days after discharge.

  From enrollment to 30 days after discharge

Study Arms (1)

albumin user group and albumin non-user group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis patients with acute variceal bleeding who were admitted to the First Affiliated Hospital, Zhejiang University School of Medicine from January 2021 to October 2023.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

CN (1)