Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation

NCT00609388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-12-08

No results posted yet for this study

Summary

The evaluation of the efficacy of an intraportal infusion with Tacrolimus, at the time of liver graft implantation, compared to a control group without immunosuppressive intraportal infusion (Placebo: Saline solution 0.9%) with respect to the initial liver function measured by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT (s), INR.

Conditions

  • Ischemia Reperfusion Injury

Interventions

DRUG

Tacrolimus

Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL

OTHER

Saline solution 0.9% (250mL)

intraoperative intraportal infusion of Saline solution 0.9% (250mL)

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Martin Bodingbauer, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Austria

Study Locations

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Entities

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 NCT00609388 on ClinicalTrials.gov