Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus (NCT01887171) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus
Belarus86 participantsStarted 2013-07
Plain-language summary
The purpose of this study is to determine whether the Tacrolimus added to histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial infusion during back-table procedure is capable of reducing the degree of early allograft liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), during first 7 postoperative days and by serum and histochemical markers of liver injury and inflammation.
Who can participate
Age range
18 Years – 69 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.
Inclusion Criteria:
* Donor:
age 15-65 years macrovesicular steatosis \< 40% (macroscopy or biopsy) sodium \<165 mmol/l ICU stay and ventilation \< 11 days cold ischemia time \< 13 hours AST \< 200 U/l ALT \< 200 U/l bilirubin \< 50 μmol/l application of norepinephrine is allowed
* Recipient age: 18-69
Exclusion Criteria:
Recipient:
* live donor liver transplant
* reduced and split grafts
* multi organ failure
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
1
Early Allograft Dysfunction
Timeframe: 1-7 postoperative days after liver transplant procedure
Trial details
NCT IDNCT01887171
SponsorRepublican Scientific and Practical Center for Organ and Tissue Transplantation