Organ Preservation Solutions
Conditions
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.
Interventions
BIOLOGICALorgan perfusion with rabbit anti-thymocyte globulin (rATG)
OTHERorgan perfusion with saline
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft function | Day 7 | Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | up to 12 month | Death rate in the investigated groups. |
| Graft loss | up to 12 month | Graft loss rate in the investigated groups. |
| HLA missmatch | Day zero, at the time point of transplantation | Human leukocyte antigen mismatches in KTx recipients. |
| Graft function - creatinine | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as serum creatinine (mg/dL) for the KTx arm. |
| Graft function - glomeralur filtration rate | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as glomerular filtration rate (ml/min/1.73M2) for the KTx arm. |
| Graft function - serum urea | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as serum urea (mg/dL) for the KTx arm. |
| Graft function - aspartate transaminase | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as aspartate transaminase (mg/dL) for LTx arm. |
| Graft function - alanine transaminase | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as alanine transaminase (mg/dL) for LTx arm. |
| Graft function - total serum bilirubin | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as total serum bilirubin (mg/dL) for LTx arm. |
| Graft function - gamma-glutamyl transpeptidase | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as gamma-glutamyl transpeptidase (mg/dL) for LTx arm. |
| Graft function - alkaline phosphatase | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as alkaline phosphatase (mg/dL) for LTx arm. |
| Graft function - quick value | Days 1-7 post transplantation, month 3, month 6, month 12 | Graft function from baseline defined as quick value (%) for LTx arm. |
| ICU stay | after transplantation | Intensive care unit stay (days) after transplantation |
| Patient age - donor | Day zero, at the time point of transplantation | Donor age (years). |
| BMI - recipient | Day zero, at the time point of transplantation | Recipient BMI (weight (lb) / \[height (in)\]2 x 703). |
| BMI - donor | Day zero, at the time point of transplantation | Donor BMI (weight (lb) / \[height (in)\]2 x 703). |
| Sex - recipient | Day zero, at the time point of transplantation | Recipient sex. |
| Sex - donor | Day zero, at the time point of transplantation | Donor sex. |
| Cold ischemia time | during transplantation | Cold ischemia time (hours) from cross-clamping until start of anastomosis. |
| Warm ischemia time | during transplantation | Warm ischemia time (hours) is the time from start of anastomosis until reperfusion. |
| Panel-reactive antibodies | Day zero, at the time point of transplantation | Presence of panel-reactive antibodies (%) in KTx recipients. |
| Hospital stay | after transplantation | Hospital stay (days) after transplantation |
| Delayed graft function | after transplantation | Development of delayed graft function (requirement of dialysis within the first 7 post operative days) in KTx recipients. |
| Experimental analysis of perioperative taken biopsies | Peri-operatively (zero hour biopsy) | mRNA Expression of pro-inflammatory and anti-inflammatory cytokine/chemokine pattern in biopsies will be analysed to evaluate immunactivation of the organ |
| Experimental analysis of peripheral blood monunuclear cells | prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood | Leukocyte-composition and activation pattern will be analysed from peripheral blood via flow cytometry of the recipient and the donor |
| Patient age - recipient | Day zero, at the time point of transplantation | Recipient age (years). |
Outcome results
None listed