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NCT04359173 Clinical Trial

Propensity Score Matched Comparison of HMP vs. SCS in Kidney Transplantation

Delayed Graft Function Clinical Trial

— HMP  

Official title:
A Retrospective Propensity Score Matched Analysis Reveals Superiority of Hypothermic Machine Perfusion Over Static Cold Storage in Deceased Donor Kidney Transplantation.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04359173
Other study ID # HMP_SCS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2015
Est. completion date March 30, 2020

Study information
Verified date April 2020
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hypothermic machine perfusion (HMP) is considered superior to static cold storage (SCS) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood.

The aim of our study is to investigate the real-world impact of HMP on kidney graft function after deceased donor kidney transplant in an HMP cohort propensity score matched with SCS.

Propensity score matching will be based on CIT, ECD, gender mismatch, CMV mismatch, re-TX and ET-senior program with a caliper of 0.05

Recruitment information / eligibility
Status Completed
Enrollment 347
Est. completion date March 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- single kidney transplantation from a deceased donor at Medical University of Innsbruck between 08/2015 and 12/2019

Exclusion Criteria:

- combined kidney transplantation with an other organ

- living donor kidney transplantation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medical University of Innsbruck Innsbruck Tyrol

Sponsors (1)
Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Delayed graft function (DGF) DGF was defined as the need for at least one dialysis within the first seven days after transplant with the exception of dialysis for hyperkalemia or hypervolemia within the first 12 hours post-transplant 7 days post transplant
Secondary graft survival 24 month graft survival 24 months post transplant
See also
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