Role of High Volume Plasma Exchange in Acute on chronic Liver failure: A Pilot Randomized Control Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the effect of high volume plasma (HVP) exchange on 28 day mortality in patients with alcohol-related ACLF.
研究概览
简要总结
Alcohol related Acute on Chronic Liver Failure (ACLF) is associated with high mortality. Presently the only definite therapy is Liver Transplantation. These patients are sick and are at risk of developing infections which make them poor candidates for Liver Transplant. In order to improve the outcome in these patients, we plan to use high volume plasma (HVP) exchange. HVP has been shown to be beneficial in patients with Acute Liver Failure and also in ACLF (reported as case reports). In this Randomized control trial, we plan to treat one arm with HVP and standard therapy and the other arm with Standard therapy alone. The result might be useful in changing the management protocol for ACLF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent.
- •> 18 years of age.
- •ACLF grade 1 or 2.
排除标准
- •ACLF grade 3
- •Systolic blood pressure < 90 mm Hg
- •Lack of informed consent
- •Coexisting severe illness eg.
- •coronary artery disease, malignancy etc
- •Post Liver Transplant patients
- •Pregnancy
- •Active infection- bacterial or fungal.
- •Hepatocellular carcinoma.
结局指标
主要结局
To study the effect of high volume plasma (HVP) exchange on 28 day mortality in patients with alcohol-related ACLF.
时间窗: 28 days
次要结局
- To study the effect of HVP on CLIF-C ACLF score, APACHE II and SIRS.(To study the effect of HVP on resolution of organ failures in ACLF.)