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Active, not recruitingNCT06348004Updated Apr 4, 2024

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

An observational study in Cirrhosis and Acute Variceal Haemorrhage, sponsored by Zhejiang University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cirrhosis
  • Acute Variceal Haemorrhage
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 500 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

Eligibility 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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • albumin user group and albumin non-user group
06

What researchers measure

Primary outcomes

  1. The rebleeding risk within 30 days after discharge.

    Time frame: From enrollment to 30 days after discharge

07

Study locations

1 site
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06348004
Lead sponsor
Zhejiang University
Responsible party
Han Ma (Dr., Zhejiang University) — Principal investigator
First posted
Apr 4, 2024
Start date
Feb 1, 2024
Primary completion
Apr 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Apr 4, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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