CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Tacrolimusdrug
Likely dose
Tacrolimus 1000 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01887171
NCT01887171N/ACompleted
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A Randomized Study of Effect of Preimplantation Portal Vein and Hepatic Artery Liver Flushing With Tacrolimus on Ischemia-reperfusion Injury, Allograft Dysfunction and Liver Histology

Republican Scientific and Practical Center for Organ and Tissue Transplantation·interventional·Posted Jun 26, 2013·Updated Feb 23, 2017

In Brief

A clinical study evaluating Tacrolimus for Early Allograft Dysfunction and 3 related conditions. Completed, enrolled 86 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Allograft Dysfunction, Ischemic Reperfusion Injury, Liver Transplantation, Hyperfibrinolysis
CountriesBelarus
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 26, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.0 years ago

Interventions

Tacrolimusdrug

1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.