Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
Primary Purpose
Kidney Transplantation, Organ Preservation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LifePort transrenal artery perfusion
LifePort transrenal vein perfusion
Sponsored by
About this trial
This is an interventional other trial for Kidney Transplantation
Eligibility Criteria
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.
Sites / Locations
- West China Hospital, Sichuan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
transrenal artery perfusion group
transrenal vein perfusion group
Arm Description
Outcomes
Primary Outcome Measures
Delayed graft function
Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.
Secondary Outcome Measures
Graft loss
Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min.
biopsy-confirmed acute rejection
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04569682
Brief Title
Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
Official Title
Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Organ Preservation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transrenal artery perfusion group
Arm Type
Active Comparator
Arm Title
transrenal vein perfusion group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LifePort transrenal artery perfusion
Intervention Description
transrenal artery perfusion group
Intervention Type
Device
Intervention Name(s)
LifePort transrenal vein perfusion
Intervention Description
transrenal vein perfusion group
Primary Outcome Measure Information:
Title
Delayed graft function
Description
Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.
Time Frame
Within one week posttransplantation
Secondary Outcome Measure Information:
Title
Graft loss
Description
Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min.
Time Frame
One year after transplantation
Title
biopsy-confirmed acute rejection
Description
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.
Time Frame
One year after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
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