Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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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.
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Study design - Single center, Open label, Randomized controlled trial
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Study period - 1 year
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Monitoring and assessment -
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ABG prior to enrollment
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Investigations - tests performed on Day 0, 1, 3, 5 and 7 or till discharge (whichever is earlier)
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Routine: CBC, RFT, LFT, apTT, PT/INR, CXR
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Coagulation parameter: ROTEM (EXTEM, FIBTEM), Fibrinogen
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Inflammatory markers: ESR, CRP, IL-6, TNF-⍺
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Endothelial dysfunction: vWF, ADAMTS-13
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Cardiac function: NT-proBNP, PRA
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2 D Echo,PFT with DLCO will be done at 0,1 and 7 days.
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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.
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Adverse effects
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Allergic reactions to albumin.
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Features of symptomatic volume overload.
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Stopping rule
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Day 7, or discharge (whichever is earlier)
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Allergic reaction to albumin
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Features of symptomatic volume overload
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Variceal bleeding
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Requirement of coagulation correct
Expected outcome of the project:
Derangement of ROTEM in the group of patients receiving human albumin solution
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
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| Active Comparator: Standard of Care Standard treatment that the patient would receive had they not been included in the trial. |
Other: Standard of Care
Standard treatment that the patient would receive had they not been included in the trial.
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Outcome Measures
Primary Outcome Measures
- Change in clotting time in both groups. [1 week]
coagulation parameters based on ROTEM
- Change in clot formation time in both groups. [1 week]
coagulation parameters based on ROTEM
- Change in maximum clot formation in both groups. [1 week]
coagulation parameters based on ROTEM
Secondary Outcome Measures
- Changes in inflammatory parameters like ESR. [7 days]
- Changes in inflammatory parameters like CRP. [7 days]
- Changes in inflammatory parameters like IL-6 [7 days]
- Changes in inflammatory parameters like TNF-alpha. [7 days]
- Changes in endothelial dysfunction like VWF. [7 days]
- Changes in endothelial dysfunction like ADAMTS-13. [7 days]
- Effect on pulmonary function by Pulmonary function test with diffusing capacity of the lungs for carbon monoxide (DLCO). [7 days]
- Effect on renal function by s.creatinine. [7 days]
- Adverse effects of Human Albumin Solution [7 days]
- Change in the albuminome in both the groups [7 days]
Albumin bound metabolites and lipids will be studied and the effect of albumin infusion on this albuminome.
- Duration of hospital stay [28 days]
- Mortality at 28 days [28 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years and ≤ 70 years
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Decompensated cirrhosis of any cause
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- Albumin ≤ 2.5 g/dl upon presentation
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Written informed consent
Exclusion Criteria:
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Patients of ACLF
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Patients admitted with proven indications for albumin (SBP, HRS, LVP)
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Advanced HCC
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Presence of hypotension
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PF ratios ≤ 300 mmHg on arterial blood gas
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IVC Collapsibility Index < 20%
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Albumin infusion within the past 3 weeks
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Post liver transplant patients
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AKI or CKD
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Known or suspected cardiac dysfunction
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Acute GI Bleed
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Severe Anemia
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Pregnant women
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PLHA
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Severe psychiatric disorders
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Lack of informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Liver & Biliary Sciences | New Delhi | Delhi | India | 110070 |
Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILBS-Cirrhosis-55