Deceased Organ Donor Interventions to Protect Kidney Graft Function

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.

Conditions

• Brain Death
• Organ Donation
• Organ Transplant Failure or Rejection
• Delayed Graft Function

Interventions

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

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.

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.

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

OTHER

Not Pump Eligible - Hypothermia

Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery.

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Darren Malinoski, MD · Oregon Health and Science University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-26

Primary Completion

2022-06-01

Completion

2022-06-01

Countries

• United States

Study Locations