CompletedNot Applicable

MicroRNA Profile As a Biomarker of Liver Damage in Different Types of Liver Donors.

Spain28 participantsStarted 2019-10-02

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

I) Main donor groups (DBD and DCD): Inclusion Criteria: * Adult deceased liver donors Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

miRNA expression profile in different types of liver donors.

Timeframe: 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.

Trial details

NCT IDNCT06611046

SponsorMar Dalmau

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-27

View on ClinicalTrials.gov More MicroRNA Profile trials