Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation (TAC-Infusion)

December 7, 2010 updated by: Medical University of Vienna

Evaluation of Tacrolimus (Prograf®) Intraportal Infusion During the Implantation and the Protective Effect on Ischemia-reperfusion Injury in Orthotopic Liver Transplant Recipients - Single Center Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General Hospital Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Multi organ transplantation or retransplantation
  • ABO incompatible donor organ recipients- Patients, who are listed on the liver transplant-waiting list at the Vienna General Hospital and who fulfill the clinical requirements (local allocation)
  • Written informed consent
  • Age > 18
  • First transplantation

Exclusion Criteria:

  • Fulminant failure of the liver
  • Liver-Living donor recipients
  • pregnant or nursing women
  • Allergy/Intolerance to antimetabolites, HCO-60, EL Cremophor or similar compounds,Steroids or macrolide antibiotics
  • HIV-positive donors or recipients
  • Participants of another clinical study
  • Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.
Drug: Tacrolimus
Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL
Other Names:
  • PROGRAF
Placebo Comparator: B
Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids.
Other: Saline solution 0.9% (250mL)
intraoperative intraportal infusion of Saline solution 0.9% (250mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Day 1,2,3; Weeks 6 and 12 post OLT
Day 1,2,3; Weeks 6 and 12 post OLT

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum parameters: TNF alpha, IL1, IL6
Time Frame: within the first 3 month
within the first 3 month
Histopathology (before and after reperfusion)
Time Frame: within the first 3 month
within the first 3 month
Frequency of rejection episodes
Time Frame: within the first 3 month
within the first 3 month
Graft function (Serum) und graft survival at 3 months post Tx
Time Frame: within the first 3 month
within the first 3 month
Patient survival at 3 months post Tx
Time Frame: within the first 3 month
within the first 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

December 8, 2010

Last Update Submitted That Met QC Criteria

December 7, 2010

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TX 001/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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