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Deceased Organ Donor Interventions to Protect Kidney Graft Function

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ClinicalTrials.gov Identifier: NCT02525510
Recruitment Status : Active, not recruiting
First Posted : August 17, 2015
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
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 - Hypothermia and Pump Right Kidney Other: Pump Eligible - Hypothermia and Pump Left Kidney Other: Not Pump Eligible - Normothermia Other: Not Pump Eligible - Hypothermia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1427 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 : March 31, 2021
Estimated Study Completion Date : December 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 - Hypothermia 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 - Hypothermia 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 - Hypothermia 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 - Hypothermia 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:

  • Donation after Cardiac Death (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


Locations
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United States, Arizona
Donor Network of Arizona
Phoenix, Arizona, United States, 85013
United States, California
U C San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Donor Alliance
Denver, Colorado, United States, 80246-1904
United States, Minnesota
LifeSource
Minneapolis, Minnesota, United States, 55411
United States, Oregon
Pacific Northwest Transplant Bank
Portland, Oregon, United States, 97201
United States, Texas
Southwest Transplant Alliance
Dallas, Texas, United States, 75231
LifeGift
Houston, Texas, United States, 77054
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:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02525510    
Other Study ID Numbers: 029669
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 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