To Study the Role of Plasma Von Willebrand Factor Antigen (vWF) to A Disintegrin-like and Metalloproteinase With Thrombospondin Type-1 Motifs 13 (ADAMTS-13) Activity Ratio as a Predictor of Development of Extrahepatic Organ Failure in Acute on Chronic Liver Failure (ACLF) Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio
研究概览
简要总结
Acute on chronic liver failure (ACLF) is a syndrome characterized by acute decompensation of chronic liver disease associated with organ failures and high short- term mortality. Development of systemic inflammation and subsequent organ failures determines is associate with poor outcome and short-term mortality. Previous studies have shown that endothelial injury leading to increase in levels of and exhaustion of its cleaving protein a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS 13) which promotes the platelet microthrombi formation and subsequent organ ischemia. We propose that the vWF : ADAMTS 13 ratio can be predict the organ failure development and subsequent mortality in ACLF patients, which is considered to be a inflammatory state.
详细描述
Null Hypothesis:
Systemic inflammation in acute-on-chronic liver failure (ACLF) leads to endothelial injury leading to increased vWF levels and exhaustion of its cleaving protein ADAMTS 13 which promotes the platelet microthrombi formation, leading to subsequent organ failures which are the strong predictors of short term mortality.
AIM: - To evaluate the role of plasma Von Willebrand factor antigen to ADAMTS-13 activity ratio in predicting organ failure in acute on chronic liver failure (ACLF) patients Objective -
Primary objective:
To study efficacy of Von Willebrand factor antigen to ADAMTS-13 activity ratio in predicting development of organ failures at day 7
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients with age >18 years who are diagnosed having ACLF fulfilling APASL ACLF criteria and do not have any extrahepatic organ failure at enrollment.
排除标准
- •Patients on antiplatelet or anticoagulant therapy for at any point of time in last 7 days
- •Pregnant female
- •Patient receiving N-acetyl cysteine (NAC) (interferes with the vWF assay)
结局指标
主要结局
Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio
时间窗: Day 7
次要结局
- Proportion of patients developing of any organ failures by day 7 with increased day 1 and day 4 vWF and ADAMTS 13 level.(Day 7)
- Proportion of patients with increased vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio across different grades of AARC ACLF(Day 28)
- Proportion of patients having change in vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio at day 7 different therapies (Nutrition, Plasma exchange, Prednisolone, Nucleos(t)ide analogue in hepatitis B) on vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio.(Day 28)
- Proportion of patients alive by day 28 without transplant with increased day 1 and day 4 vWF and ADAMTS 13 level.(Day 28)
- Proportion of patients having change in vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio compared to change in AARC, MELD, CLIF-ACLF scores(Day 28)
- Proportion of patients alive by day 28 without transplant with increased vWF: ADAMTS 13 ratio.(Day 28)