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OpenTrials
Completed

NCT Number: NCT04569682

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

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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Key information

Conditions

Kidney Transplantation Organ Preservation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult recipients older than 18 years;
  • 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;
  • First single kidney transplantation;
  • The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
  • Ethics committee approved.

Exclusion criteria

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

Treatment and study plan

LifePort transrenal artery perfusion

Device

transrenal artery perfusion group

LifePort transrenal vein perfusion

Device

transrenal vein perfusion group

Primary outcomes

  1. Delayed graft function

    Time frame: Within one week posttransplantation

    Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.

Secondary outcomes

  1. Graft loss

    Time frame: One year after transplantation

    Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min.

  2. biopsy-confirmed acute rejection

    Time frame: One year after transplantation

    biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 30, 2020
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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