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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplantation Organ Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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transrenal artery perfusion group

Group Type ACTIVE_COMPARATOR

LifePort transrenal artery perfusion

Intervention Type DEVICE

transrenal artery perfusion group

transrenal vein perfusion group

Group Type EXPERIMENTAL

LifePort transrenal vein perfusion

Intervention Type DEVICE

transrenal vein perfusion group

Interventions

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LifePort transrenal artery perfusion

transrenal artery perfusion group

Intervention Type DEVICE

LifePort transrenal vein perfusion

transrenal vein perfusion group

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No