NCT00224705已完成3 期
Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Patient survival at six months
研究概览
简要总结
The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by:
- Reducing the number of patients who die before a graft is available
- Increasing the chances of survival without a liver transplant
- Reducing the pre- and post-operative mortality in transplant patients
详细描述
Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:
- A group treated with the conventional medical intensive treatment (including the hemodialysis techniques, continuous veno-venous hemofiltration or hemodiafiltration, if necessary) and the gold standard surgical treatment (liver transplantation) compared to
- A group receiving, in addition to the conventional medical intensive treatment, albumin dialysis using the MARS device and the gold standard surgical treatment (liver transplantation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation
排除标准
- •Sepsis severe not controlled
- •Haemorrhage activates not controlled
- •Clinical Obviousness of disseminated intravascular coagulation
- •Severe Pathology cardiopulmonary (NYHA > or = 2)
- •Pregnancy, breast feeding
- •Average blood Pressure < 40 mmHg more than 10 minutes in spite of a support by the inotrope
- •Nonhepatic coma of origin
- •Cholestases extra-hepatitic
- •Antecedents of heavy surgery in the 4 previous weeks or surgical problems unsolved
- •Absolute counter-indication with hepatic transplantation (extra Neoplasia hepatic evolutionary, irreversible cerebral Attack, irreversible multi-visceral Failure, visceral tares contra-indicating the transplantation)
- •Positive serology HIV
- •Hepatic Demonstrations of the malignant hemopathies
- •Participation in another therapeutic test in the 4 previous weeks
结局指标
主要结局
Patient survival at six months
时间窗: 6 months
次要结局
- Patient survival at six months without neurological sequelae(6 months)
- Patient survival at 1 year(during one year)
- Graft survival at six months and 1 year(at 6 months and at one year)
- Number of patients who improve their liver function and no longer need a transplant in each stage of the trial(during one year)
- Hospital mortality before the transplant(during one year)
- Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)(during one year)
- Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function(during one year)
- Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)(during one year)
- Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant(during one year)
- duration of hospitalisation(during one year)
研究者
研究点 (2)
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