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Albumin for liver disease

Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D): An Open-label Randomized Control Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050591
Enrollment
120
Registered
2023-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Albumin: Dose: Those with serum albumin levels between 3-3.5 gm/dL will receive 100 mL of 20% human albumin solution.Those with 2.5-3 gm/dL will receive 200 mL of 20% human albumin solu

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and 2. Decompensated cirrhosis of any cause 3. S. Albumin 4. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients of ACLF 2. Patients admitted with proven indications for albumin (SBP, HRS, LVP) 3. Advanced HCC 4. Presence of hypotension 5. PF ratios 6. IVC Collapsibility Index 7. Albumin infusion within the past 3 weeks 8. Post liver transplant patients 9. AKI or CKD 10. Known or suspected cardiac dysfunction 11. Acute GI Bleed 12. Severe Anemia 13. Pregnant women 14. PLHA 15. Severe psychiatric disorders 16. Lack of informed consent

Design outcomes

Primary

MeasureTime frame
To study the effect of albumin on ROTEM based coagulation parameters within the first week in decompensated cirrhotic patientsTimepoint: 1 week

Secondary

MeasureTime frame
Adverse effects of HASTimepoint: 7 days;Alterations in the albuminomeTimepoint: 7 days;Changes in endothelial dysfunctionTimepoint: 7 days;Changes in inflammatory parametersTimepoint: 7 days;Duration of hospital stayTimepoint: 28 days;Effect on cardio-pulmonary and renal functionTimepoint: 7 days;Mortality at 28 daysTimepoint: 28 days

Countries

India

Contacts

Public ContactDr Manoj Kumar Sharma

Institute of Liver and Biliary Sciences

manojkumardm@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026