Deceased Organ Donor Interventions to Protect Kidney Graft Function
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02525510 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2015
Last Update Posted : May 25, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 |

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, 2022 |
Estimated Study Completion Date : | March 31, 2022 |

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

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
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 |
Principal Investigator: | Darren Malinoski, MD | Oregon Health and Science University |
Publications:
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: | May 25, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Mild Hypothermia Machine Perfusion Kidney Transplantation |
Brain Death Delayed Graft Function Death Pathologic Processes Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Coma Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |