CTRI/2023/04/052118招募中3 期
Rifaximin, Therapeutic plasma exchange, and Granuolcyte-Colony stimulating factor with Standard Medical Therapy(SMT) Versus SMT in Severe Alcoholic Hepatitis- A Randomized Controlled trial - GRACE-AH
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Severe Alcoholic hepatitis patients worsening or remaining static on standard medical therapy. aged 18 to 80 years, giving valid Informed consent
排除标准
- •Hepatocellular carcinoma or active malignancy
- •Portal vein thrombosis
- •Spleen size more than 18cm
- •Prior treatment with glucocorticoids
- •Renal failure (creatinine more than or equal to 2 mg/dL)
- •Mean arterial pressure less than 70 mm Hg or requirement of vasopressors
- •PF ratio lesser than or equal to 200 or mechanically ventilated for respiratory failure
- •Uncontrolled UGI-bleed within last 48 hrs
- •HIV infection, chronic viral hepatitis (HBV and HCV)
- •Autoimmune hepatitis, Wilson disease, hemochromatosis
- •Macrophage activation syndrome
- •CLIF-C ACLF score more than 60, AARC score more than or equal to 11
- •Uncontrolled infection or sepsis
- •Known hypersensitivity to G-CSF, plasma, Albumin, Rifaximin
- •Lack of informed consent
- •Post liver transplant patients
研究者
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