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

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Medical University of Vienna

Status and phase

Completed
Phase 4

Conditions

Ischemia Reperfusion Injury

Treatments

Other: Saline solution 0.9% (250mL)
Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00609388
TX 001/07

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups, including a placebo group

A
Active Comparator group
Description:
Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.
Treatment:
Drug: Tacrolimus
B
Placebo Comparator group
Description:
Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids.
Treatment:
Other: Saline solution 0.9% (250mL)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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