CTRI/2023/01/048789尚未招募不适用
Liver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs (CHANCE) Study on behalf of the EASL-CLIF Consortium
European Foundation for the Study of Chronic Liver Failure1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- To estimate the 1-year graft and patient survival rate after liver transplant (LT) in ACLF 2/3 with patients with decompensated cirrhosis with ACLF 2 and 3
研究概览
简要总结
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation (LT) as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximizing LT success. Alternative strategies, such as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potentially life-threatening complications in the donor.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with the diagnosis of liver cirrhosis
- •subjects who have been hospitalized for acute decomposition of liver cirrhosis and referred to the transplant team
- •Patients who have been informed and signed for informed consent.
排除标准
- •Acute or subacute liver failure without underlying cirrhosis
- •Patients with hepatocellular carcinoma outside Milan criteria or other active neoplasia
- •Subjects listed for transplantation other than the liver or liver-kidney transplant
- •Subjects with previous liver transplantation
- •Vulnerable population
- •Pregnant and/ or breastfeeding women Patients who cannot provide prior informed consent
- •Patients and team not committed to providing intensive care if needed
- •Patients with relevant comorbidities that could impact the prognosis: Subjects with very severe hepatopulmonary syndrome subjects with severe pulmonary disease obstructive lung disease subjects with chronic kidney disease requiring hemodialysis subjects with severe heart disease subjects with known infection with HIV subjects with neurological or psychiatric disorders.
结局指标
主要结局
To estimate the 1-year graft and patient survival rate after liver transplant (LT) in ACLF 2/3 with patients with decompensated cirrhosis with ACLF 2 and 3
时间窗: 0,3,6,9,12 months
次要结局
- To identify factors in decision-making for listing patients with severe ACLF to transplant team(To compare the clinical course of patients with ACLF2/3 with decompensated cirrhosis without ACLF 2/3)
研究者
研究点 (1)
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