MedTrace Logo

Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus

NCT01887171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2017-02-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Early Allograft Dysfunction
  • Ischemic Reperfusion Injury
  • Liver Transplantation
  • Hyperfibrinolysis

Interventions

DRUG

Tacrolimus

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.

Sponsors & Collaborators

  • Republican Scientific and Practical Center for Organ and Tissue Transplantation

    lead OTHER

Principal Investigators

  • Aliaksei E Shcherba, PhD · RSPC for tissue and organ transplantation

  • Oleg O Rumo, MD PhD · RSPC for organ and tissue transplantation, Minsk 9th clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Belarus

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887171 on ClinicalTrials.gov