Clinical trial NCT05937048: Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).
Official title: Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D): An Open-label Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompensated Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients.
timeFrame: 3 days
Secondary outcomes:
measure: Changes in inflammatory parameters like ESR.
timeFrame: 3 days
measure: Changes in inflammatory parameters like CRP.
timeFrame: 3 days
measure: Changes in inflammatory parameters like IL-6
timeFrame: 3 days
measure: Changes in inflammatory parameters like TNF-alpha.
timeFrame: 3 days
measure: Changes in endothelial dysfunction like VWF.
timeFrame: 3 days
measure: Changes in endothelial dysfunction like ADAMTS-13.
timeFrame: 3 days
measure: Effect on pulmonary function by Pulmonary function test
timeFrame: 3 days
measure: Effect on renal function by s.creatinine.
timeFrame: 3 days
measure: Adverse effects of Human Albumin Solution
timeFrame: 3 days
measure: Change in the albuminome in both the groups
timeFrame: 3 days
measure: Duration of hospital stay
timeFrame: 28 days
measure: Mortality at 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: