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
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
-
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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