NCT04359173

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4.4 years

First QC Date

April 20, 2020

Last Update Submit

April 22, 2020

Conditions

Delayed Graft Function

Keywords

kidney transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • graft survival

    24 months post transplant

Study Arms (2)

Hypothermic machine perfusion (HMP)

patients who underwent kidney transplantation following HMP

Static cold storage (SCS)

patients who underwent kidney transplantation following SCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • combined kidney transplantation with an other organ
  • living donor kidney transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan Schneeberger, Prof.

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

August 1, 2015

Primary Completion

December 31, 2019

Study Completion

March 30, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)