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

NCT ID: NCT00609388

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Ischemia Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

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

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

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

B

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

Group Type PLACEBO_COMPARATOR

Saline solution 0.9% (250mL)

Intervention Type OTHER

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

Interventions

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Tacrolimus

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

Intervention Type DRUG

Saline solution 0.9% (250mL)

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

Intervention Type OTHER

Other Intervention Names

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PROGRAF

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna / Dep. of Transplantation

Principal Investigators

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Martin Bodingbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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General Hospital Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type RESULT
PMID: 12548508 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21672049 (View on PubMed)

Other Identifiers

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TX 001/07

Identifier Type: -

Identifier Source: org_study_id