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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00609388
First received: January 24, 2008
Last updated: December 7, 2010
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Ischemia Reperfusion Injury
Drug: Tacrolimus
Other: Saline solution 0.9% (250mL)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

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. [ Time Frame: Day 1,2,3; Weeks 6 and 12 post OLT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum parameters: TNF alpha, IL1, IL6 [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Histopathology (before and after reperfusion) [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Frequency of rejection episodes [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Graft function (Serum) und graft survival at 3 months post Tx [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]
  • Patient survival at 3 months post Tx [ Time Frame: within the first 3 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.
Drug: Tacrolimus
Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL
Other Name: PROGRAF
Placebo Comparator: B
Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids.
Other: Saline solution 0.9% (250mL)
intraoperative intraportal infusion of Saline solution 0.9% (250mL)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00609388

Locations
Austria
General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Martin Bodingbauer, MD Medical University of Vienna
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Martin Bodingbauer, Medical University of Vienna / Dep. of Transplantation
ClinicalTrials.gov Identifier: NCT00609388     History of Changes
Other Study ID Numbers: TX 001/07
Study First Received: January 24, 2008
Last Updated: December 7, 2010
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014