A Prospective, Multi-Centre, Propensity Score Based Matched Pair Controlled, Study of Standard Medical Care Plus CytoSorb® 300 mL Device Compared to Standard Medical Care Alone in Patients With Acute on Chronic Liver Failure Due to Severe Alcoholic Hepatitis in Combination With Systemic Hyperinflammation and Acute on Chronic Liver Failure Score ≥2
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2
研究概览
简要总结
The objective of this study is to assess the safety and performance of the CytoSorb® therapy in patients with Acute on Chronic Liver Failure (ACLF) grade ≥ 2 due to a severe alcohol induced hepatitis (Maddrey DF > 32) and a severe inflammatory response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form (ICF)
- •Total bilirubin ≥ 8 mg/dL
- •Acute Alcoholic Hepatitis diagnosed by EtOH consumption within 6 weeks of onset of symptoms, exclusion of other causes for jaundice and liver biopsy or at least 2 out of the following symptoms:
- •Hepatomegaly
- •AST > ALT
- •Elevated WBC
- •Maddrey DF > 32
- •Systemic inflammation as defined by 2 fulfilled criteria out of:
- •leucocytosis
- •body temperature > 38°C
- •tachycardia > 90 bpm
- •tachypnoeia > 20 breaths/min
- •ACLF grade ≥2
- •Creatinine >2 mg/dl and increase >1.5 mg/dl despite standard of care
排除标准
- •Platelets < 40,000/mm3
- •MELD Score > 35
- •AST > 500 IU/l
- •Bilirubin reduction > 20% in prior 72 hours (early responders to conventional Standard of Care (SOC))
- •Uncontrolled infection, bleeding or hemodynamic instability
- •Small liver size (diagnosed by imaging, ultrasound/CT)
- •Chronic dialysis
- •Contraindications for CytoSorb® according to Instructions for Use
- •ACLF grade <2
结局指标
主要结局
Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2
时间窗: 7 Days
To evaluate effectiveness of the CytoSorb® treatment compared to control group by comparing the proportion of patients in each group with ACLF grade \<2 at the end of Day 7 after CytoSorb® therapy start (assessed by https://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf).
Safety of CytoSorb treatment
时间窗: 30 Days
To evaluate if CytoSorb® treatment plus Standard Medical Care (SMC) compared to SMC alone is safe and tolerable as assessed by the incidence of SA(D)Es, ADEs, DDs, SADEs, and USADEs. SAE - Severe Adverse Effect; ADE - Adverse Device Effect; SADE - Severe Adverse Device Effect; DD - Device Deficiencies; USADE - Unexpected Serious Adverse Device Effect
次要结局
未报告次要终点