CTRI/2022/06/042973招募中未知
iver 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 - CHANCE STUDY
EASLCLIF Consortium0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or female subject =18 years of age.
- •2. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
- •3. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:
- •Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.
- •Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD >20) at the time of listing.
- •Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.
- •4. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria
排除标准
- •A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study.
- •1.Acute or subacute liver failure without underlying cirrhosis.
- •2.Patients with hepatocellular carcinoma outside Milan criteria or other active neoplasia.
- •3.Subjects listed for transplantation other than liver or liver-kidney transplant.
- •4.Subjects with previous liver transplantation.
- •5.Vulnerable population (person under temporary or permanent guardianship or deprived of liberty by a judicial decision).
- •6.Pregnant and/or breastfeeding woman
- •7.Patients with relevant comorbidities that could impact the prognosis:
- •oSubjects with very severe hepatopulmonary syndrome (with PaO2 < 50 mmHg on FiO2 21%) or moderate to severe portopulmonary hypertension (non-reversible mPAP = 35 mmHg or PVR = 500 dyn.s.cm-5).
- •oSubjects with severe (grade IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
- •oSubjects with chronic kidney disease requiring hemodialysis
- •oSubjects with severe heart disease (NYHA class III and IV)
- •oSubjects with a known infection with human immunodeficiency virus (HIV)
- •oSubjects with severe neurological or psychiatric disorders
- •8.Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
- •9.Physician and team not committed to provide intensive care if needed.
研究者
相似试验
尚未招募
不适用
Indications and outcomes of cirrhosis and acute on chronic liver failure patients undergoing liver transplantatioCTRI/2023/01/048789European Foundation for the Study of Chronic Liver Failure
尚未招募
不适用
iver transplantation in patients with CirrHosis and severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs (CHANCE)NL-OMON52056European Foundation for the study of Chronic Liver Failure (EF-Clif)105
已完成
不适用
Chinese Herbal Medicine Formula Jieduhuayu Granules Improves Cognitive and Neurophysiological Functions in Patients with Cirrhosis Who Have Minimal Hepatic EncephalopathyACTRN12614000193673ational Natural Science Foundation of China80
招募中
不适用
Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEsLiver DiseasesLiver Transplant ComplicationsAcute-On-Chronic Liver FailureLiver CirrhosisNCT04613921European Foundation for Study of Chronic Liver Failure3,000
已完成
2 期
Mesenchymal Stem Cell Transplantation in Decompensated CirrhosisCirrhosisNCT00476060University of Tehran27