A Randomized Controlled Trial to Study the Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Transplant free survival in both group
研究概览
简要总结
In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.
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
- Double (Participant, Investigator)
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-18-70 years
- •Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)
- •Grade IV DILI With T.B > 15
- •DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option
排除标准
- •Evidence of active infection
- •Refusal of consent or assent
- •Patients with clinical suspicion of irreversible brain injury
- •Pregnancy
- •HCC (Hepatocellular Carcinoma) or any other malignancy
- •Kidney failure
- •Portal vein thrombosis
- •Upper GastroIntestinal bleed
- •Transplant
研究组 & 干预措施
High Volume Plasma Exchange with SMT
PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity.
Standard Medical Treatment (Albumin + High Caloric Diet)
干预措施: High Volume Plasma Exchange (Biological)
High Volume Plasma Exchange with SMT
PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity.
Standard Medical Treatment (Albumin + High Caloric Diet)
干预措施: Standard Medical Treatment (Other)
Standard Medical Treatment
Standard Medical Treatment (Albumin + High Caloric Diet)
干预措施: Standard Medical Treatment (Other)
结局指标
主要结局
Transplant free survival in both group
时间窗: Day 28
次要结局
- Number of participants with the development of organ dysfunction or failure in both group(Day 28)