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Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).

NCT05937048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-04

No results posted yet for this study

Summary

Albumin is commonly used plasma expander in patients of decompensated cirrhosis and has been found to have many beneficial effects, with few studies showing that maintenance of serum albumin levels above 3 g/dl has improved outcomes and mortality leading to widespread utilization in patients with cirrhosis of the liver.

While 20% human albumin solution has been subject to in-depth analysis along several fronts, it's effects on coagulation parameters is unknown. With cirrhosis being a state of dysregulated clotting and bleeding, it is imperative to know the effects of such a widely used plasma expander on coagulation.

The aim of this study is to evaluate the effects of albumin on coagulation parameters in patients of decompensated cirrhosis.

Conditions

  • Decompensated Cirrhosis

Interventions

BIOLOGICAL

Albumin

20% human albumin solution infusion, to raise and maintain serum albumin levels above 3.0 g/dl. Human albumin solution will be given to those enrolled in the study having serum albumin levels ≤ 3 g/dl to maintain the serum albumin levels above 3 g/dl.

OTHER

Standard of Care

Standard treatment that the patient would receive had they not been included in the trial.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2024-11-25
Completion
2024-11-25

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937048 on ClinicalTrials.gov