Comparing the efficacy of low volume vs standard volume plasma exchange in patients with Acute Liver Failure - A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To assess efficacy of plasma exchange in terms of mortality on day 30.
研究概览
简要总结
The study will be conducted in the Department of Transfusion Medicine in collaboration with the Department of Hepatology (PGIMER, Chandigarh). A convenient sample size of 42 patients (21 in each group) to be enrolled in the study after obtaining a written informed consent. After enrollment in the study, the patients will be randomized into two groups.
Group I: Patients will undergo Low Voume Plasma Exchange, after informed consent.
Group II: Patients will undergo Standard Volume Plasma Exchange, after informed consent.
The baseline investigations and the clinical details will be recorded as per proforma. Patients will be randomized to low volume or standard volume plasma exchange. Primary and Secondary outcomes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with acute liver failure as per EASL/INASL/AASLD criteria.
- •No evidence of active infection.
- •Willing to give informed consent.
- •Those who are not enrolled in any other study.
- •Patients who are not intended for liver transplantation.
排除标准
- •Microbiological or radiological evidence of infection.
- •Known allergy to plasma, Protamine or Heparin.
- •Severe systemic illness like HIV.
- •Active hemorrhage.
- •Liver, Kidney or any other transplant recipients will be excluded.
- •Severe pre existing cardiopulmonary disease.
- •Coexisting HCC or any other malignancy.
- •Death within 24 hours of presentation.
结局指标
主要结局
To assess efficacy of plasma exchange in terms of mortality on day 30.
时间窗: To assess efficacy of plasma exchange in terms of mortality on day 30.
次要结局
- Improvement in ALFED score, SOFA score, Clinical Prognostic index, KCH criteria to be assessed on pre procedure and on day 1,3,5,7 post procedure. Hematological and biochemical parameters will be assessed.(On day 0(pre procedure), post procedure day 1,3,5,7)
研究者
Anu Ragavan
Post Graduate Institute of Medical Education and Research