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Deceased Organ Donor Interventions to Protect Kidney Graft Function

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ClinicalTrials.gov Identifier: NCT02525510
Recruitment Status : Recruiting
First Posted : August 17, 2015
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Claus Niemann, University of California, San Francisco

Brief Summary:
To protect kidney function during the transplantation process by comparing mild hypothermia in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney after recovery and prior to transplantation.

Condition or disease Intervention/treatment Phase
Brain Death Organ Donation Organ Transplant Failure or Rejection Delayed Graft Function Other: Pump Eligible - Normothermia - Pump Both Kidneys Other: Pump Eligible - Hyporthermia and Pump Right Kidney Other: Pump Eligible - Hyporthermia and Pump Left Kidney Other: Not Pump Eligible - Normothermia Other: Not Pump Eligible - Hypothermia Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Enrolled donors will be divided into two populations based on local Organ Procurement Organization criteria:Pump Eligible and Not Pump Eligible.

Pump Eligible will include three arms. Not Pump Eligible will include two arms.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Mild Hypothermia and Machine Perfusion in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : July 26, 2020
Estimated Study Completion Date : July 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Pump Eligible - Normothermia - Pump Both Kidneys
Normothermia and Machine Perfusion Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery. Recovered kidneys will receive machine perfusion prior to implantation.
Other: Pump Eligible - Normothermia - Pump Both Kidneys
Normothermia and Machine Perfusion Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery. Recovered kidneys will receive machine perfusion prior to implantation.OPO's protocol

Active Comparator: Pump Eligible - Hyporthermia and Pump Right Kidney
Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Right Kidney will receive machine perfusion prior to implantation and the Left Kidney will receive cold storage.
Other: Pump Eligible - Hyporthermia and Pump Right Kidney

Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Right Kidney will receive machine perfusion prior to implantation and the Left Kidney will receive cold storage.

Recovered kidneys will be placed in University of Wisconsin for cold storage until reimplantation.


Active Comparator: Pump Eligible - Hyporthermia and Pump Left Kidney
Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Left Kidney will receive machine perfusion prior to implantation and the Right Kidney will receive cold storage.
Other: Pump Eligible - Hyporthermia and Pump Left Kidney
Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Left Kidney will receive machine perfusion prior to implantation and the Right Kidney will receive cold storage.

Active Comparator: Not Pump Eligible - Normothermia
Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery.
Other: Not Pump Eligible - Normothermia

Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery.

Pulsatile Perfusion of kidney grafts based on the respective OPO's protocol


Active Comparator: Not Pump Eligible - Hypothermia
Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery.
Other: Not Pump Eligible - Hypothermia
Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery.




Primary Outcome Measures :
  1. Delayed Graft Function in Kidney Allografts [ Time Frame: 7 days ]
    The incidence of DGF in kidneys from deceased donors enrolled in this trial, obtained from publically available OPTN data.


Secondary Outcome Measures :
  1. Allograft and Recipient survival for all transplanted organs [ Time Frame: 1 year ]
    Allograft and Recipient survival for all transplanted organs from deceased donors enrolled in this trial obtained from publically available OPTN data.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years of age,
  • Brain dead organ donor,
  • Authorization for research

Exclusion Criteria:

  • DCD Donor
  • Coagulopathy, Hemodynamic instability, Electrolyte deficiencies, Pre-existing kidney disease (per study protocol)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525510


Contacts
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Contact: Claus Niemann, MD 415-502-2162 Claus.Niemann@ucsf.edu
Contact: Darren Malinoski, MD 503-220-8262 ext 55613 malinosk@ohsu.edu

Locations
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United States, Arizona
Donor Network of Arizona Recruiting
Phoenix, Arizona, United States, 85013
Contact: PJ Geraghty, MBA, CPTC       PJ@dnaz.org   
Contact: Kayla Gray, CCRP       kayla.gray@dnaz.org   
United States, California
U C San Francisco Active, not recruiting
San Francisco, California, United States, 94143
United States, Colorado
Donor Alliance Recruiting
Denver, Colorado, United States, 80246-1904
Contact: Katherine Fitting, MD       kfitting@donoralliance.org   
Contact: Lauren Abernathy       labernathy@donoralliance.org   
United States, Minnesota
LifeSource Recruiting
Minneapolis, Minnesota, United States, 55411
Contact: William Payne, MD       payne001@umn.edu   
Contact: Kate Kishish, RN       kkishish@life-source.org   
United States, Oregon
Pacific Northwest Transplant Bank Recruiting
Portland, Oregon, United States, 97201
Contact: Craig Van De Walker       vandewac@ohsu.edu   
Contact: Rachel Nelson       nelsonra@ohsu.edu   
United States, Texas
Southwest Transplant Alliance Recruiting
Dallas, Texas, United States, 75231
Contact: Jeffrey Reese, MD       jreese@organ.org   
Contact: Walker Jason       jwalker@organ.org   
LifeGift Recruiting
Houston, Texas, United States, 77054
Contact: R. Patrick Wood, MD       rpwood@lifegift.org   
Contact: Monique Ferguson       mferguson@lifegift.org   
Sponsors and Collaborators
University of California, San Francisco
Oregon Health and Science University
Investigators
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Principal Investigator: Darren Malinoski, MD Oregon Health and Science University

Additional Information:
Publications of Results:
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Responsible Party: Claus Niemann, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02525510     History of Changes
Other Study ID Numbers: 029669
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claus Niemann, University of California, San Francisco:
Mild Hypothermia
Machine Perfusion
Kidney Transplantation
Additional relevant MeSH terms:
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Brain Death
Delayed Graft Function
Pathologic Processes
Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations