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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05937048
• Other study ID #: ILBS-Cirrhosis-55
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: February 27, 2024

Study information

• Verified date: February 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Omkar S Rudra, MD
• Phone: 01146300000
• Email: dr.orudra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Other:
• Standard of Care
Standard treatment that the patient would receive had they not been included in the trial.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clotting time in both groups.	coagulation parameters based on ROTEM	1 week
Primary	Change in clot formation time in both groups.	coagulation parameters based on ROTEM	1 week
Primary	Change in maximum clot formation in both groups.	coagulation parameters based on ROTEM	1 week
Secondary	Changes in inflammatory parameters like ESR.		7 days
Secondary	Changes in inflammatory parameters like CRP.		7 days
Secondary	Changes in inflammatory parameters like IL-6		7 days
Secondary	Changes in inflammatory parameters like TNF-alpha.		7 days
Secondary	Changes in endothelial dysfunction like VWF.		7 days
Secondary	Changes in endothelial dysfunction like ADAMTS-13.		7 days
Secondary	Effect on pulmonary function by Pulmonary function test with diffusing capacity of the lungs for carbon monoxide (DLCO).		7 days
Secondary	Effect on renal function by s.creatinine.		7 days
Secondary	Adverse effects of Human Albumin Solution		7 days
Secondary	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.	7 days
Secondary	Duration of hospital stay		28 days
Secondary	Mortality at 28 days		28 days