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

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

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