Peri-operative rATG-perfusion of Solid Transplants
- Conditions
- Organ Preservation Solutions
- Interventions
- Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG)Other: organ perfusion with saline
- Registration Number
- NCT03377283
- Lead Sponsor
- Medical University Innsbruck
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- patients receiving a kidney or liver transplant from deceased donors
- Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AP-KTx/LTx organ perfusion with rabbit anti-thymocyte globulin (rATG) Transplant recipients receiving an rATG-perfused kidney or liver CP-KTx/LTx organ perfusion with saline Transplant recipients receiving a control-perfused kidney or liver.
- Primary Outcome Measures
Name Time Method Graft function Day 7 Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).
- Secondary Outcome Measures
Name Time Method 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 - quick value Days 1-7 post transplantation, month 3, month 6, month 12 Graft function from baseline defined as quick value (%) for LTx arm.
BMI - recipient Day zero, at the time point of transplantation Recipient BMI (weight (lb) / \[height (in)\]2 x 703).
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 - 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 - 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 - 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.
Patient age - recipient Day zero, at the time point of transplantation Recipient age (years).
BMI - donor Day zero, at the time point of transplantation Donor BMI (weight (lb) / \[height (in)\]2 x 703).
Hospital stay after transplantation Hospital stay (days) after transplantation
HLA missmatch Day zero, at the time point of transplantation Human leukocyte antigen mismatches in KTx recipients.
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 - 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.
Cold ischemia time during transplantation Cold ischemia time (hours) from cross-clamping until start of anastomosis.
Panel-reactive antibodies Day zero, at the time point of transplantation Presence of panel-reactive antibodies (%) in KTx recipients.
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).
Sex - recipient Day zero, at the time point of transplantation Recipient sex.
Sex - donor Day zero, at the time point of transplantation Donor sex.
Mortality up to 12 month Death rate in the investigated groups.
Graft loss up to 12 month Graft loss rate in the investigated groups.
Warm ischemia time during transplantation Warm ischemia time (hours) is the time from start of anastomosis until reperfusion.
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
Delayed graft function after transplantation Development of delayed graft function (requirement of dialysis within the first 7 post operative days) in KTx recipients.