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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06348004
Other study ID # 2024IIT-0125
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date April 2024

Study information

Verified date March 2024
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rebleeding risk within 30 days after discharge. From enrollment to 30 days after discharge
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