Clinical trial NCT03377283: Peri-operative rATG-perfusion of Solid Transplants
Official title: Reduction of Ischemic-reperfusion Injury by Ex-vivo ATG-perfusion of Kidneys and Livers Prior Organ Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Organ Preservation Solutions
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The increasing demand for organ transplantation and the shortage of available organs limit the success of organ transplantation programs. Consequently, acceptance of expanded criteria donor (ECD) organs with the consequences of higher risk of unfavorable transplantation outcome has become an increasing reality. Among the most prominent characteristics distinguishing ECD from Standard Criteria Donors (SCD) are risk factors including brain death (BD) or prolonged cold ischemia time (CI) amplifying ischemia reperfusion injury (IRI). Currently there are no standard regimens to improve the quality of ECD organs. Therefore, donor organ treatment might be a promising approach to substantially improve organ quality. It will be investigated whether the application of the peri-operative perfusion of kidneys and livers with the polyclonal antibody rabbit antithymocyte globulin (rATG) ameliorates IRI.

This trial is designed as a parallel armed randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* patients receiving a kidney or liver transplant from deceased donors

Exclusion Criteria:

* Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian

Primary outcomes:
measure: Graft function
timeFrame: Day 7
Secondary outcomes:
measure: Graft function - creatinine
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - glomeralur filtration rate
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - serum urea
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - aspartate transaminase
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - alanine transaminase
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - total serum bilirubin
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - gamma-glutamyl transpeptidase
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - alkaline phosphatase
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Graft function - quick value
timeFrame: Days 1-7 post transplantation, month 3, month 6, month 12
measure: Patient age - recipient
timeFrame: Day zero, at the time point of transplantation
measure: Patient age - donor
timeFrame: Day zero, at the time point of transplantation
measure: BMI - recipient
timeFrame: Day zero, at the time point of transplantation
measure: BMI - donor
timeFrame: Day zero, at the time point of transplantation
measure: Sex - recipient
timeFrame: Day zero, at the time point of transplantation
measure: Sex - donor
timeFrame: Day zero, at the time point of transplantation
measure: Cold ischemia time
timeFrame: during transplantation
measure: Warm ischemia time
timeFrame: during transplantation
measure: Panel-reactive antibodies
timeFrame: Day zero, at the time point of transplantation
measure: Hospital stay
timeFrame: after transplantation
measure: ICU stay
timeFrame: after transplantation
measure: Mortality
timeFrame: up to 12 month
measure: Graft loss
timeFrame: up to 12 month
measure: HLA missmatch
timeFrame: Day zero, at the time point of transplantation
measure: Delayed graft function
timeFrame: after transplantation
measure: Experimental analysis of perioperative taken biopsies
timeFrame: Peri-operatively (zero hour biopsy)
measure: Experimental analysis of peripheral blood monunuclear cells
timeFrame: prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood
Other outcomes:
Locations:
Study officials:
References:
citation: Ritschl PV, Gunther J, Hofhansel L, Kuhl AA, Sattler A, Ernst S, Friedersdorff F, Ebner S, Weiss S, Bosmuller C, Weissenbacher A, Oberhuber R, Cardini B, Ollinger R, Schneeberger S, Biebl M, Denecke C, Margreiter C, Resch T, Aigner F, Maglione M, Pratschke J, Kotsch K. Graft Pre-conditioning by Peri-Operative Perfusion of Kidney Allografts With Rabbit Anti-human T-lymphocyte Globulin Results in Improved Kidney Graft Function in the Early Post-transplantation Period-a Prospective, Randomized Placebo-Controlled Trial. Front Immunol. 2018 Aug 24;9:1911. doi: 10.3389/fimmu.2018.01911. eCollection 2018.