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

This study has been completed.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00609388

First received: January 24, 2008

Last updated: December 7, 2010

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2008

Last Updated Date

December 7, 2010

Start Date ^ICMJE

January 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00609388 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Ischemia Reperfusion Injury

Intervention ^ICMJE

Drug: Tacrolimus
Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL

Other Name: PROGRAF
Other: Saline solution 0.9% (250mL)
intraoperative intraportal infusion of Saline solution 0.9% (250mL)

Study Arm (s)

Active Comparator: A
Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.

Intervention: Drug: Tacrolimus
Placebo Comparator: B
Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids.

Intervention: Other: Saline solution 0.9% (250mL)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00609388

Other Study ID Numbers ^ICMJE

TX 001/07

Has Data Monitoring Committee

Responsible Party

Dr. Martin Bodingbauer, Medical University of Vienna / Dep. of Transplantation

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Martin Bodingbauer, MD

Medical University of Vienna

Information Provided By

Medical University of Vienna

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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