Peri-operative rATG-perfusion of Solid Transplants
NCT03377283 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2017-12-22
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
- BIOLOGICAL
-
organ perfusion with rabbit anti-thymocyte globulin (rATG)
- OTHER
-
organ perfusion with saline
Sponsors & Collaborators
-
Medical University Innsbruck
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-17
- Primary Completion
- 2015-03-04
- Completion
- 2016-02-24
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