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

Primary Purpose

Ischemia Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Tacrolimus
Saline solution 0.9% (250mL)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia Reperfusion Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

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.

Secondary Outcome Measures

Serum parameters: TNF alpha, IL1, IL6
Histopathology (before and after reperfusion)
Frequency of rejection episodes
Graft function (Serum) und graft survival at 3 months post Tx
Patient survival at 3 months post Tx

Full Information

First Posted
January 24, 2008
Last Updated
December 7, 2010
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00609388
Brief Title
Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation
Acronym
TAC-Infusion
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
PROGRAF
Intervention Description
Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL
Intervention Type
Other
Intervention Name(s)
Saline solution 0.9% (250mL)
Intervention Description
intraoperative intraportal infusion of Saline solution 0.9% (250mL)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Serum parameters: TNF alpha, IL1, IL6
Time Frame
within the first 3 month
Title
Histopathology (before and after reperfusion)
Time Frame
within the first 3 month
Title
Frequency of rejection episodes
Time Frame
within the first 3 month
Title
Graft function (Serum) und graft survival at 3 months post Tx
Time Frame
within the first 3 month
Title
Patient survival at 3 months post Tx
Time Frame
within the first 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bodingbauer, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
12548508
Citation
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. doi: 10.1053/jlts.2003.50018.
Results Reference
result
PubMed Identifier
21672049
Citation
Kristo I, Wilflingseder J, Kainz A, Marschalek J, Wekerle T, Muhlbacher 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. doi: 10.1111/j.1432-2277.2011.01284.x. Epub 2011 Jun 14.
Results Reference
derived

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

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