Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D): An Open-label Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 70 years
- •Decompensated cirrhosis of any cause
- •S. Albumin ≤ 2.5 g/dl upon presentation
- •Written informed consent
排除标准
- •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
- •Severe psychiatric disorders
- •Lack of informed consent
研究组 & 干预措施
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.
干预措施: Albumin (Biological)
Standard of Care
Standard treatment that the patient would receive had they not been included in the trial.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in ROTEM based coagulation parameters with albumin infusion in decompensated cirrhotic patients.
时间窗: 3 days
ROTEM based parameters includes CT,CFT,A10,A20,MCF (EXTEM). CT,CFT,A10,A20 (FIBTEM)
次要结局
- Change in the albuminome in both the groups(3 days)
- Duration of hospital stay(28 days)
- Mortality at 28 days(28 days)
- Adverse effects of Human Albumin Solution(3 days)
- Changes in inflammatory parameters like IL-6(3 days)
- Changes in inflammatory parameters like TNF-alpha.(3 days)
- Changes in endothelial dysfunction like VWF.(3 days)
- Changes in endothelial dysfunction like ADAMTS-13.(3 days)
- Effect on pulmonary function by Pulmonary function test(3 days)
- Effect on renal function by s.creatinine.(3 days)
- Changes in inflammatory parameters like ESR.(3 days)
- Changes in inflammatory parameters like CRP.(3 days)