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

Ischemia Reperfusion Injury Clinical Trial

— TAC-Infusion  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609388
• Other study ID #: TX 001/07
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: December 7, 2010
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury

Intervention

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

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

Locations

Country	Name	City	State
Austria	General Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Serum parameters: TNF alpha, IL1, IL6		within the first 3 month	Yes
Secondary	Histopathology (before and after reperfusion)		within the first 3 month	Yes
Secondary	Frequency of rejection episodes		within the first 3 month	Yes
Secondary	Graft function (Serum) und graft survival at 3 months post Tx		within the first 3 month	Yes
Secondary	Patient survival at 3 months post Tx		within the first 3 month	Yes