Effect of Therapeutic Plasma Exchange on Liver Transplantation-free Survival in Amanita Toxin-induced Acute Liver Failure - a Multicenter Retrospective Study Over 10 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 6
- 主要终点
- Liver Transplant free Survival
研究概览
简要总结
Retrospective evaluation of the value of additive therapeutic plasma exchange (PEX) compared to standard medical therapy (SMT) in Amanita toxin-associated acute liver failure in children and adolescents within the last 10 years at a international group of liver transplant centers.
详细描述
Amanita toxin-associated acute liver failure is a life-threatening condition that can often lead to the need for an emergency liver transplantation. The disease may also be fatal, particularly in patients who are not eligible for a liver transplant due to advanced age or corresponding comorbidities.
Therapeutic plasma exchange treatment has been shown to significantly improve patient survival in other cases of acute liver failure and has since become standard treatment for acute liver failure in many, but not all, liver transplant centers. However, no patients with Amanita toxin-associated acute liver failure were included in these cohorts.
The hypothesis of the planned study is that an additive therapeutic plasma exchange treatment (PEX) can improve liver transplantation-free survival in these patients compared to standard medical therapy (SMT) alone. Since the therapy procedure in different transplant centers in differs with regard to the use of therapeutic plasma exchange, we are therefore planning a multicenter retrospective comparison of PEX with SMT with regard to transplant-free survival and other clinical endpoints. For this very small cohort of patients with acute liver failure, which also varies in frequency depending on the season and weather conditions, there will certainly never be a sufficiently powered randomized and controlled study. This analysis may change the standard procedure for patients with Amanita toxin-associated acute liver failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute liver failure (presence of hepatic encephalopathy of grade I or higher and a coagulopathy with an INR > 1.5)
- •Amanita Toxin related acute liver failure
排除标准
- •Acute liver failure of other reason than Amanita Toxin
- •Amanita Toxin associated Hepatitis or severe hepatitis without fulfilling the criteria of acute liver failure
结局指标
主要结局
Liver Transplant free Survival
时间窗: until day 28 from initial diagnosis of acute liver failure
Survival and free of liver transplantation until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR \> 1.5)
次要结局
- Liver transplantation(until day 28 from initial diagnosis of acute liver failure)
- Overall Survival(until day 28 from initial diagnosis of acute liver failure)
- Vasopressor therapy(until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5))
- High urgency (HU) listing for liver transplantation(until day 28 from initial diagnosis of acute liver failure)
- Acute kidney injury (AKI) and max. grade of AKI (I-III)(until day 28 from initial diagnosis of acute liver failure)
- Renal Replacement Therapy (RRT)(until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5))
- Maximum grade of hepatic encephalopathy (HE)(until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5))
- Invasive ventilation(until day 28 from initial diagnosis of acute liver failure (encephalopathy of any grade and coagulopathy with INR > 1.5))
研究者
Stahl, Klaus Dr.
PD Dr. Klaus Stahl, PD Dr. Richard Taubert, Dr. Bahar Nalbant
Hannover Medical School