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

Decompensated Cirrhosis Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

• NCT number: NCT05937048
• Study type: Interventional
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Omkar S Rudra, MD
• Phone: 01146300000
• Email: dr.orudra@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2023
• Completion date: February 27, 2024