Peri-operative rATG-perfusion of Solid Transplants

Medical University Innsbruck

Status and phase: Completed; Phase 4

Conditions: Organ Preservation Solutions

Treatments: Other: organ perfusion with saline; Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03377283

UN4640

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

AP-KTx/LTx

Active Comparator group

Description:

Transplant recipients receiving an rATG-perfused kidney or liver

Treatment:

Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG)

CP-KTx/LTx

Placebo Comparator group

Description:

Transplant recipients receiving a control-perfused kidney or liver.

Treatment:

Other: organ perfusion with saline