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

Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D): An Open-label Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Decompensated Cirrhosis
• Intervention / Treatment: Biological: Albumin; Other: Standard of Care

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Standard of Care; Standard treatment that the patient would receive had they not been included in the trial.	Other: Standard of Care; Standard treatment that the patient would receive had they not been included in the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients.	ROTEM based parameters includes CT,CFT,A10,A20,MCF (EXTEM). CT,CFT,A10,A20 (FIBTEM)	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay		28 days
Mortality at 28 days		28 days
Changes in inflammatory parameters like ESR.		3 days
Changes in inflammatory parameters like CRP.		3 days
Changes in inflammatory parameters like IL-6		3 days
Changes in inflammatory parameters like TNF-alpha.		3 days
Changes in endothelial dysfunction like VWF.		3 days
Changes in endothelial dysfunction like ADAMTS-13.		3 days
Effect on pulmonary function by Pulmonary function test		3 days
Effect on renal function by s.creatinine.		3 days
Adverse effects of Human Albumin Solution		3 days
Change in the albuminome in both the groups	Albumin bound metabolites and lipids will be studied and the effect of albumin infusion on this albuminome.	3 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2023
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No