Tissue Analysis (Histological, Ultrastructural and Molecular) of Liver Grafts as a Predictor of Transplant Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Identification of specific '"endothelial signatures"
研究概览
简要总结
Despite the good clinical results in terms of outcome with the application of HOPE prior to liver transplantation, very little is still known about the phenotypic and molecular changes that occur during perfusion/preservation during HOPE, particularly with regard to endothelial trophism and activation. Delving into these aspects would be very useful to allow personalised perfusion treatments in the future, thus improving the outcome of transplantation.
详细描述
The primary aim of the study is the identification of specific 'endothelial signatures' (markers on tissue with immunohistochemistry and gene expression with RT-PCR) in liver grafts after HOPE treatment, predictive of transplant outcome. Interventional study without drug, including two cohorts of patients: (1) liver donors, on whom an allocation biopsy for organ quality will be performed (as standard of care); (2) liver recipients (from donors in cohort 1) on whom a study-specific biopsy will be performed as soon as the transplant has taken place (after vascular anastomoses with organ revascularisation). The study-specific biopsy constitutes the intervention of the study; patients will be treated according to the judgement of the physician and the information reported in the Technical Data Sheet of each product of any concomitant therapies administered according to clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Donors:
- •Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
- •HOPE performed on the liver graft prior to transplantation.
- •For Recipients:
- •Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
- •Age greater than/equal to 18 years.
排除标准
- 未提供
研究组 & 干预措施
Organ donors
organ donors (legally deceased, brain death or cardiac death)
干预措施: histochemical and immunohistochemical analysis (Diagnostic Test)
Organ donors
organ donors (legally deceased, brain death or cardiac death)
干预措施: RT-PCR (Diagnostic Test)
Organ recipients
Organ recipients
干预措施: histochemical and immunohistochemical analysis (Diagnostic Test)
Organ recipients
Organ recipients
干预措施: RT-PCR (Diagnostic Test)
结局指标
主要结局
Identification of specific '"endothelial signatures"
时间窗: Within 24 months
Main outcomes to assess the outcome of transplantation will be the percentage of early (PNF and EAD, within 1 week after transplantation) and late (rejection and complications) complications, as well as mortality among recipients within 24 months.
次要结局
未报告次要终点