Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Early Allograft dysfunction (EAD)
研究概览
简要总结
A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD.
The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for liver transplantation following National and International Guidelines
排除标准
- •No agreement or inability to give informed consent
- •Re-transplant patients
- •Liver transplant in fulminant hepatitis
结局指标
主要结局
Early Allograft dysfunction (EAD)
时间窗: 2 weeks from Liver transplantation
Olthoff criteria: bilirubina≥ 10 mg/dL in 7th post-operative day, international normalized ratio (INR) ≥ 1.6 in 7th post-operative day 7; ALT or AST\> 2000 IU/L during the first 7 days after liver transplantation
次要结局
未报告次要终点