NCT03377283

Peri-operative rATG-perfusion of Solid Transplants

Reduction of Ischemic-reperfusion Injury by Ex-vivo ATG-perfusion of Kidneys and Livers Prior Organ Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Organ Preservation Solutions

Interventions

Type	Name	Description
BIOLOGICAL	organ perfusion with rabbit anti-thymocyte globulin (rATG)
OTHER	organ perfusion with saline

Timeline

• Start date: 2012-08-17
• Primary completion: 2015-03-04
• Completion: 2016-02-24
• First posted: 2017-12-19
• Last updated: 2017-12-22