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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Graft function
Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).
Time frame: Day 7
Graft function - creatinine
Graft function from baseline defined as serum creatinine (mg/dL) for the KTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - glomeralur filtration rate
Graft function from baseline defined as glomerular filtration rate (ml/min/1.73M2) for the KTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - serum urea
Graft function from baseline defined as serum urea (mg/dL) for the KTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - aspartate transaminase
Graft function from baseline defined as aspartate transaminase (mg/dL) for LTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - alanine transaminase
Graft function from baseline defined as alanine transaminase (mg/dL) for LTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - total serum bilirubin
Graft function from baseline defined as total serum bilirubin (mg/dL) for LTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - gamma-glutamyl transpeptidase
Graft function from baseline defined as gamma-glutamyl transpeptidase (mg/dL) for LTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - alkaline phosphatase
Graft function from baseline defined as alkaline phosphatase (mg/dL) for LTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - quick value
Graft function from baseline defined as quick value (%) for LTx arm.
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Patient age - recipient
Recipient age (years).
Time frame: Day zero, at the time point of transplantation
Patient age - donor
Donor age (years).
Time frame: Day zero, at the time point of transplantation
BMI - recipient
Recipient BMI (weight (lb) / \[height (in)\]2 x 703).
Time frame: Day zero, at the time point of transplantation
BMI - donor
Donor BMI (weight (lb) / \[height (in)\]2 x 703).
Time frame: Day zero, at the time point of transplantation
Sex - recipient
Recipient sex.
Time frame: Day zero, at the time point of transplantation
Sex - donor
Donor sex.
Time frame: Day zero, at the time point of transplantation
Cold ischemia time
Cold ischemia time (hours) from cross-clamping until start of anastomosis.
Time frame: during transplantation
Warm ischemia time
Warm ischemia time (hours) is the time from start of anastomosis until reperfusion.
Time frame: during transplantation
Panel-reactive antibodies
Presence of panel-reactive antibodies (%) in KTx recipients.
Time frame: Day zero, at the time point of transplantation
Hospital stay
Hospital stay (days) after transplantation
Time frame: after transplantation
ICU stay
Intensive care unit stay (days) after transplantation
Time frame: after transplantation
Mortality
Death rate in the investigated groups.
Time frame: up to 12 month
Graft loss
Graft loss rate in the investigated groups.
Time frame: up to 12 month
HLA missmatch
Human leukocyte antigen mismatches in KTx recipients.
Time frame: Day zero, at the time point of transplantation
Delayed graft function
Development of delayed graft function (requirement of dialysis within the first 7 post operative days) in KTx recipients.
Time frame: after transplantation
Experimental analysis of perioperative taken biopsies
mRNA Expression of pro-inflammatory and anti-inflammatory cytokine/chemokine pattern in biopsies will be analysed to evaluate immunactivation of the organ
Time frame: Peri-operatively (zero hour biopsy)
Experimental analysis of peripheral blood monunuclear cells
Leukocyte-composition and activation pattern will be analysed from peripheral blood via flow cytometry of the recipient and the donor
Time frame: prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood
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