drugset / Trial / NCT03377283

Peri-operative rATG-perfusion of Solid Transplants

NCT03377283

Phase 4 Completed 80 enrolled Medical University Innsbruck
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-08-17
Primary completion
2015-03-04
Completion
2016-02-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thymoglobulin Protein / enzyme biologic Other

Indications

No indication recorded.