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

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00609388

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 IV

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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
B: Placebo Comparator 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

Contacts

Contact: Martin Bodingbauer, MD

+43-1-40400 ext 6873

martin.bodingbauer@meduniwien.ac.at

Locations

Austria
General Hospital Vienna	Recruiting
Vienna, Austria, 1090
Contact: Martin Bodingbauer, MD +43-1-40400 ext 6873 martin.bodingbauer@meduniwien.ac.at
Principal Investigator: Martin Bodingbauer, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Martin Bodingbauer, MD

Medical University of Vienna

More Information

Publications of Results:

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.

Responsible Party:	Medical University of Vienna / Dep. of Transplantation ( Dr. Martin Bodingbauer )
Study ID Numbers:	TX 001/07
Study First Received:	January 24, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00609388
Health Authority:	Austria: Agency for Health and Food Safety

Study placed in the following topic categories:

Postoperative Complications
Vascular Diseases
Tacrolimus
Ischemia
Reperfusion Injury

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs

Cardiovascular Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009