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OpenTrials
Completed

NCT Number: NCT00609388

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

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.

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Key information

Conditions

Ischemia Reperfusion Injury Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

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

Other names: PROGRAF

Saline solution 0.9% (250mL)

Other

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

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.

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

Secondary outcomes

  1. Serum parameters: TNF alpha, IL1, IL6

    Time frame: within the first 3 month

  2. Histopathology (before and after reperfusion)

    Time frame: within the first 3 month

  3. Frequency of rejection episodes

    Time frame: within the first 3 month

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

    Time frame: within the first 3 month

  5. Patient survival at 3 months post Tx

    Time frame: within the first 3 month

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Acronym: TAC-Infusion

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2008
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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