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

Purpose

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:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Tacrolimus

U.S. FDA Resources

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)

Eligibility

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

Criteria

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.

Contacts and Locations

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

Locations

Austria
General Hospital Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Martin Bodingbauer, MD

Medical University of Vienna

More Information

Publications:

St Peter SD, Post DJ, Rodriguez-Davalos MI, Douglas DD, Moss AA, Mulligan DC. Tacrolimus as a liver flush solution to ameliorate the effects of ischemia/reperfusion injury following liver transplantation. Liver Transpl. 2003 Feb;9(2):144-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kristo I, Wilflingseder J, Kainz A, Marschalek J, Wekerle T, Mühlbacher F, Oberbauer R, Bodingbauer M. Effect of intraportal infusion of tacrolimus on ischaemic reperfusion injury in orthotopic liver transplantation: a randomized controlled trial. Transpl Int. 2011 Sep;24(9):912-9. Epub 2011 Jun 14.

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:

Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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