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

This study has been completed.
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
First received: January 24, 2008
Last updated: December 7, 2010
Last verified: December 2007
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.

Condition Intervention Phase
Ischemia Reperfusion Injury
Drug: Tacrolimus
Other: Saline solution 0.9% (250mL)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum parameters: TNF alpha, IL1, IL6 [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Histopathology (before and after reperfusion) [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Frequency of rejection episodes [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Graft function (Serum) und graft survival at 3 months post Tx [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Patient survival at 3 months post Tx [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00609388

General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Martin Bodingbauer, MD Medical University of Vienna
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Martin Bodingbauer, Medical University of Vienna / Dep. of Transplantation
ClinicalTrials.gov Identifier: NCT00609388     History of Changes
Other Study ID Numbers: TX 001/07 
Study First Received: January 24, 2008
Last Updated: December 7, 2010
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Reperfusion Injury
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Vascular Diseases
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2016