Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation

Sichuan University

Status: Completed

Conditions: Organ Preservation; Kidney Transplantation

Treatments: Device: LifePort transrenal artery perfusion; Device: LifePort transrenal vein perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04569682

WestChina-LifePort

Details and patient eligibility

About

The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult recipients older than 18 years;
2. Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation;
3. First single kidney transplantation;
4. The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
5. Ethics committee approved.

Exclusion criteria

1. Patients less than 18 years old, or more than 65 years old;
2. Patients who receive multiple organ transplants;
3. Diagnosed with malignancy or had a history of malignancy in the past 5 years;
4. non-kidney transplantation history.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

transrenal artery perfusion group

Active Comparator group

Treatment:

Device: LifePort transrenal artery perfusion

transrenal vein perfusion group

Experimental group

Treatment:

Device: LifePort transrenal vein perfusion