NCT00609388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2007

Enrollment Period

2.9 years

First QC Date

January 24, 2008

Last Update Submit

December 7, 2010

Conditions

Ischemia Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1,2,3; Weeks 6 and 12 post OLT

Secondary Outcomes (5)

  • Serum parameters: TNF alpha, IL1, IL6

    within the first 3 month

  • Histopathology (before and after reperfusion)

    within the first 3 month

  • Frequency of rejection episodes

    within the first 3 month

  • Graft function (Serum) und graft survival at 3 months post Tx

    within the first 3 month

  • Patient survival at 3 months post Tx

    within the first 3 month

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Tacrolimus

B

PLACEBO COMPARATOR

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

Other: Saline solution 0.9% (250mL)

Interventions

TacrolimusDRUG

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

Also known as: PROGRAF
A
Saline solution 0.9% (250mL)OTHER

intraoperative intraportal infusion of Saline solution 0.9% (250mL)

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

  • 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.

    PMID: 12548508RESULT

  • 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.

    PMID: 21672049DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Interventions

TacrolimusSaline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Martin Bodingbauer, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 8, 2010

Record last verified: 2007-12

Locations

AU(1)