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

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

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

Study Overview

• Status: Completed
• Conditions: Delayed Graft Function

• Study Type: Observational
• Enrollment (Actual): 347

Contacts and Locations

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University of Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All deceased donor kidney transplants performed between 08/2015 and 12/2019

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hypothermic machine perfusion (HMP); patients who underwent kidney transplantation following HMP
Static cold storage (SCS); patients who underwent kidney transplantation following SCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
graft survival	24 month graft survival	24 months post transplant

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Stefan Schneeberger, Prof., Medical University of Innsbruck

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: kidney transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function
• Other Study ID Numbers: HMP_SCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No