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

NCT05937048 | Completed

• 1 other identifier: ILBS-Cirrhosis-55
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

Study Arms (2)

Albumin

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Albumin 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.

Albumin

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Albumins; Standard of Care

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: July 10, 2023
• Study Start: July 30, 2023
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: June 4, 2025

Record last verified: 2024-06

Locations

IN (1)