跳至主要内容
临床试验/CTRI/2024/09/073862
CTRI/2024/09/073862尚未招募3 期

Efficacy of plasma exchange in patients with acute on chronic Liver failure A randomized controlled trial

MMCSBY Scheme Government of Rajasthan1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
To compare survival over 30 days in PLEX and SMT arm

研究概览

简要总结

ACLF has a high short term mortality with the Standard Medical Treatment (SMT). Liver Transplantation (LT) is the only curative treatment. There are many devices that aim to artificially support liver function to bridge patients to liver transplantation and eventually allow for recompensation. Theraupeutic plasma exchange (PLEX) has shown to improve survival in few studies but has not been validated yet. Purpose of this study is to statistically compare and evaluate the 30 day survival in ACLF patients in PLEX patients vs SMT group. Also, improvement in renal failure , hepatic encephalopathy , PLEX related complications , duration of hospital stay , serial vWF levels are compared.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All ethologies of ACLF as per APASAL criteria will be included in the study.

排除标准

  • Active sepsis Hemodynamic instability HIV infection Malignancy HCC Pregnancy Alcoholic hepatitis and Severe Alcoholic hepatitis.

结局指标

主要结局

To compare survival over 30 days in PLEX and SMT arm

时间窗: To compare survival over 30 days in PLEX and SMT arm

次要结局

  • Improvement in renal dysfunction(Improvement in hepatic encephalopathy)

研究者

发起方
MMCSBY Scheme Government of Rajasthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sandeep Nijhawan

SMS Medical College and Hospital, Jaipur

研究点 (1)

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