NCT02525510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 26, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

4.9 years

First QC Date

August 6, 2015

Last Update Submit

June 10, 2022

Conditions

Brain DeathOrgan DonationOrgan Transplant Failure or RejectionDelayed Graft Function

Keywords

Mild HypothermiaMachine PerfusionKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Delayed Graft Function in Kidney Allografts

    The incidence of DGF in kidneys from deceased donors enrolled in this trial, obtained from publically available OPTN data.

    7 days

Secondary Outcomes (1)

  • Allograft and Recipient survival for all transplanted organs

    1 year

Study Arms (5)

Pump Eligible - Normothermia - Pump Both Kidneys

ACTIVE COMPARATOR

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

Pump Eligible - Hypothermia and Pump Right Kidney

ACTIVE COMPARATOR

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

Pump Eligible - Hypothermia and Pump Left Kidney

ACTIVE COMPARATOR

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

Not Pump Eligible - Normothermia

ACTIVE COMPARATOR

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

Other: Not Pump Eligible - Normothermia

Not Pump Eligible - Hypothermia

ACTIVE COMPARATOR

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

Other: Not Pump Eligible - Hypothermia

Interventions

Pump Eligible - Normothermia - Pump Both KidneysOTHER

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

Pump Eligible - Normothermia - Pump Both Kidneys
Pump Eligible - Hypothermia and Pump Right KidneyOTHER

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.

Pump Eligible - Hypothermia and Pump Right Kidney
Pump Eligible - Hypothermia and Pump Left KidneyOTHER

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.

Pump Eligible - Hypothermia and Pump Left Kidney
Not Pump Eligible - NormothermiaOTHER

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

Not Pump Eligible - Normothermia
Not Pump Eligible - HypothermiaOTHER

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

Not Pump Eligible - Hypothermia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Donor Network of Arizona

Phoenix, Arizona, 85013, United States

Location

U C San Francisco

San Francisco, California, 94143, United States

Location

Donor Alliance

Denver, Colorado, 80246-1904, United States

Location

LifeSource

Minneapolis, Minnesota, 55411, United States

Location

Pacific Northwest Transplant Bank

Portland, Oregon, 97201, United States

Location

Southwest Transplant Alliance

Dallas, Texas, 75231, United States

Location

LifeGift

Houston, Texas, 77054, United States

Location

Related Publications (6)

  • Niemann CU, Feiner J, Swain S, Bunting S, Friedman M, Crutchfield M, Broglio K, Hirose R, Roberts JP, Malinoski D. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015 Jul 30;373(5):405-14. doi: 10.1056/NEJMoa1501969.

    PMID: 26222557BACKGROUND

  • Jochmans I, Watson CJ. Taking the Heat Out of Organ Donation. N Engl J Med. 2015 Jul 30;373(5):477-8. doi: 10.1056/NEJMe1507573. No abstract available.

    PMID: 26222564BACKGROUND

  • Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.

    PMID: 19118301BACKGROUND

  • Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

    PMID: 38979743DERIVED

  • Patel MS, Salcedo-Betancourt JD, Saunders C, Broglio K, Malinoski D, Niemann CU. Therapeutic Hypothermia in Low-Risk Nonpumped Brain-Dead Kidney Donors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2353785. doi: 10.1001/jamanetworkopen.2023.53785.

    PMID: 38416500DERIVED

  • Malinoski D, Saunders C, Swain S, Groat T, Wood PR, Reese J, Nelson R, Prinz J, Kishish K, Van De Walker C, Geraghty PJ, Broglio K, Niemann CU. Hypothermia or Machine Perfusion in Kidney Donors. N Engl J Med. 2023 Feb 2;388(5):418-426. doi: 10.1056/NEJMoa2118265.

    PMID: 36724328DERIVED

Related Links

MeSH Terms

Conditions

Brain DeathRejection, PsychologyDelayed Graft Function

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Officials

  • Darren Malinoski, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 17, 2015

Study Start

July 26, 2017

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(7)