Status:
COMPLETED
Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors
Lead Sponsor:
University Hospital, Aachen
Conditions:
Reperfusion Injury
Hypothermic Oxygenated Machine Perfusion
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an...
Detailed Description
The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to ...
Eligibility Criteria
Inclusion
- Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.
- ECD is defined as followed: deceased donors \> 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension
Exclusion
- Recipients of living donor kidney transplants
- Previous kidney transplantation
- Participation in other kidney related trials
- The subject received an investigational drug within 30 days prior to inclusion
- The subject is unwilling or unable to follow the procedures outlined in the protocol
- The subject is mentally or legally incapacitated
- Non-German or non-English speakers
- Family members of the investigators or employees of the participating department
- The subject is mentally or legally incapacitated
- The subject suffers from uncontrolled bacterial or viral infection
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03378817
Start Date
December 5 2017
End Date
March 30 2020
Last Update
April 7 2020
Active Locations (1)
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1
Department of Surgery and Transplantation, University Hospital RWTH Aachen
Aachen, Germany, 52074