Perfil De MicroRNA Como Biomarcador De Daño Hepático En Diferentes Tipos De Donantes De Hígado (MicroRNA Profile As a Biomarker of Liver Damage in Different Types of Liver Donors).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- miRNA expression profile in different types of liver donors.
研究概览
简要总结
The goal of this observational study is to analyze the expression of liver-derived miRNAs in different types of liver donors to gain in depth knowledge about distinctive physiologic features within donors and find potential biomarkers for graft quality assessment. The main questions it aims to answer are:
Is there a distinctive miRNA profile between donors after brain-stem death and donors after circulatory death?
Is heparinase I treatment necessary to overcome miRNA quantification interference in heparinized liver donor samples ?
Researchers will compare miRNA expression in donors after brain-stem death and donors after circulatory death with I) a subgroup of donors with unusable grafts due to significant steatosis, 2) and with a subgroup of healthy controls undergoing elective cholecystectomy to set the reference miRNA profiles in extreme conditions.
详细描述
Between October 2019 and May 2021, perfusates, liver biopsies and serum samples were collected prospectively from adult deceased organ donors in Vall d'Hebron University Hospital, Barcelona, Spain.
Samples from adult human brain death donors (n=10) and donors after circulatory death (n=10) were analyzed for the presence of miR-122, miR-148, miR-155, miR-22, miR-222 and ratio miR122/miR222, target biomarkers of liver injury selected from the literature.
To set the reference miRNA profiles, a subgroup of donors with unusable grafts due to significant steatosis (n=3) were analyzed.
Donors for re-transplantation, pediatric, and split were excluded to avoid biopsy-related injury.
As there were no living donor inclusions in the study period, serum specimens from a subgroup of healthy controls undergoing elective cholecystectomy (n=7) were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult deceased liver donors
排除标准
- •Pediatric donors (less than18 year-old)
- •Donors for re-transplantation cases
- •Donors who underwent split or partition liver technique to obtain two small grafts for two recipients (adult and pediatric).
- •II) Discarded DBD grafts:
- •Inclusion Criteria:
- •Unusable grafts for transplantation due to moderate (30% to 60%) or severe (more than 60%) steatosis in liver biopsies.
- •Exclusion Criteria:
- •Unusable grafts discarded for other reasons.
- •Pediatric donors (less than18 year-old)
- •Donors for re-transplantation cases
- •Donors who underwent split or partition liver technique to obtain two small grafts for two recipients (adult and pediatric).
- •III) Control group:
- •Inclusion criteria:
- •Same inclusion criteria as the living liver donor program in our center: 18 to 60 years old, normal liver function, ultrasound without signs of liver disease and steatosis less than 30%.
- •Exclusion criteria:
- •Patients with preoperative deranged liver function tests.
结局指标
主要结局
miRNA expression profile in different types of liver donors.
时间窗: Data collection from regional donors in a period of two years based on donor availability and main investigator (data collector) availability. The samples were collected during organ procurement which entails over 4 to 6 hours in each donor.
Compare the miRNA expression profile (miR-122 and miR-148a, miR-222, miR-22 and miR-155) from death brain donors and circulatory death donors in liver biopsies, serum and perfusion solution
次要结局
未报告次要终点
研究者
Mar Dalmau
Specialist in General Surgery and Digestive System
Hospital Vall d'Hebron