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

NCT ID: NCT05937048

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2024-11-25

Brief 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.

Detailed Description

Aim and Objective:

To study the effects of 20% human albumin infusions on coagulation parameters in patients with decompensated cirrhosis of the liver.

Methodology:

• Study population: All patients aged ≥ 18 years and ≤ 70 years admitted in Institute of Liver and Biliary Sciences, New Delhi with decompensated cirrhosis of any cause and S. Albumin ≤ 2.5 g/dl upon presentation and are giving written consent for participation in the study.

• Study design - Single center, Open label, Randomized controlled trial
• Study period - 1 year
• Monitoring and assessment -
• ABG prior to enrollment
• Investigations - tests performed on Day 0, 1, 3, 5 and 7 or till discharge (whichever is earlier)

• Routine: CBC, RFT, LFT, apTT, PT/INR, CXR
• Coagulation parameter: ROTEM (EXTEM, FIBTEM), Fibrinogen
• Inflammatory markers: ESR, CRP, IL-6, TNF-⍺
• Endothelial dysfunction: vWF, ADAMTS-13
• Cardiac function: NT-proBNP, PRA
• 2 D Echo,PFT with DLCO will be done at 0,1 and 7 days.
• Statistical Analysis:

The data will be represented as mean±SD. The categorical data will be analysed using Chi-square test. The continuous data will be analysed by student T test, or Mann-Whitney test, whichever is applicable. Besides this, Cox regression will be applied to analyse the variables. For all tests, p≤ 0.05 will be considered statistically significant.

• Adverse effects
• Allergic reactions to albumin.
• Features of symptomatic volume overload.
• Stopping rule
• Day 7, or discharge (whichever is earlier)
• Allergic reaction to albumin
• Features of symptomatic volume overload
• Variceal bleeding
• Requirement of coagulation correct

Expected outcome of the project:

Derangement of ROTEM in the group of patients receiving human albumin solution

Conditions

Decompensated Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Albumin

Intervention Type: BIOLOGICAL

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.

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BIOLOGICAL

Standard of Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years and ≤ 70 years
• Decompensated cirrhosis of any cause
• S. Albumin ≤ 2.5 g/dl upon presentation
• Written informed consent

Exclusion Criteria

• Patients of ACLF
• Patients admitted with proven indications for albumin (SBP, HRS, LVP)
• Advanced HCC
• Presence of hypotension
• PF ratios ≤ 300 mmHg on arterial blood gas
• IVC Collapsibility Index < 20%
• Albumin infusion within the past 3 weeks
• Post liver transplant patients
• AKI or CKD
• Known or suspected cardiac dysfunction
• Acute GI Bleed
• Severe Anemia
• Pregnant women
• PLHA
• Severe psychiatric disorders
• Lack of informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-Cirrhosis-55

Identifier Type: -

Identifier Source: org_study_id