Decompensated CirrhosisNCT05937048
Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).
A study testing Albumin in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jul 2023to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 70 years
- Decompensated cirrhosis of any cause
- S. Albumin ≤ 2.5 g/dl upon presentation
- Written informed consent
Who cannot join
- 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%
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D): An Open-label Randomized Control Trial
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.
Read the 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
- Conditions
- Decompensated Cirrhosis
- Being tested
- Albumin, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminBiological
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.
Standard of CareOther
Standard treatment that the patient would receive had they not been included in the trial.
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Experimental | 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. Receives: Biological: Albumin |
| Standard of Care | Active comparator | Standard treatment that the patient would receive had they not been included in the trial. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients.
ROTEM based parameters includes CT,CFT,A10,A20,MCF (EXTEM). CT,CFT,A10,A20 (FIBTEM)
Measured: 3 days
Secondary outcomes (12)
Changes in inflammatory parameters like ESR.
Measured: 3 days
Changes in inflammatory parameters like CRP.
Measured: 3 days
Changes in inflammatory parameters like IL-6
Measured: 3 days
Changes in inflammatory parameters like TNF-alpha.
Measured: 3 days
Changes in endothelial dysfunction like VWF.
Measured: 3 days
Changes in endothelial dysfunction like ADAMTS-13.
Measured: 3 days
Effect on pulmonary function by Pulmonary function test
Measured: 3 days
Effect on renal function by s.creatinine.
Measured: 3 days
Adverse effects of Human Albumin Solution
Measured: 3 days
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.
Measured: 3 days
Duration of hospital stay
Measured: 28 days
Mortality at 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start30 Jul 2023
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937048
- Sponsor's protocol ID
- ILBS-Cirrhosis-55
- Status last verified
- Jun 2024
- First submitted
- 20 Feb 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D): An Open-label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05937048
- Acronym / sponsor ID
- ILBS-Cirrhosis-55
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Experimental | Biological: Albumin20% 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. |
| Standard of Care | Active comparator | Other: Standard of CareStandard treatment that the patient would receive had they not been included in the trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤ 70 years
- Decompensated cirrhosis of any cause
- S. Albumin ≤ 2.5 g/dl upon presentation
- Written informed consent
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin20% 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 |
| Standard of CareStandard treatment that the patient would receive had they not been included in the trial. | Other | Standard of Care |
Primary outcome
Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients.
Time frame: 3 days
ROTEM based parameters includes CT,CFT,A10,A20,MCF (EXTEM). CT,CFT,A10,A20 (FIBTEM)
12 secondary outcomes
Changes in inflammatory parameters like ESR.
Time frame: 3 days
Changes in inflammatory parameters like CRP.
Time frame: 3 days
Changes in inflammatory parameters like IL-6
Time frame: 3 days
Changes in inflammatory parameters like TNF-alpha.
Time frame: 3 days
Changes in endothelial dysfunction like VWF.
Time frame: 3 days
Changes in endothelial dysfunction like ADAMTS-13.
Time frame: 3 days
Effect on pulmonary function by Pulmonary function test
Time frame: 3 days
Effect on renal function by s.creatinine.
Time frame: 3 days
Adverse effects of Human Albumin Solution
Time frame: 3 days
Change in the albuminome in both the groups
Time frame: 3 days
Duration of hospital stay
Time frame: 28 days
Mortality at 28 days
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.