10°C vs 4°C Lung Preservation RCT

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 9, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

July 1, 2026

Conditions
Lung TransplantOrgan Preservation
Interventions
DEVICE

Lung transplantation after 10°C donor lung preservation

When suitable donor lungs become available for a, eligible, consented recipient and meet criteria to go straight to transplantation, the lungs randomized to 10°C preservation will be stored, transported and preserved in the X°Port Lung Transport Device (Traferox Technologies Inc.) until implant with a maximum time of 12 hours between the donor and recipient surgeries.

DEVICE

Lung transplantation after standard ice cooler donor lung preservation

When suitable donor lungs become available for a, eligible, consented recipient and meet criteria to go straight to transplantation, the lungs randomized to standard preservation will be will be stored, transported and preserved in an ice cooler (\~4°C, standard of care) until implant with a maximum time of 6 hours between the donor and recipient surgeries.

Trial Locations (14)

2010

RECRUITING

St Vincent's Hospital Sydney Limited, Sydney

33146

RECRUITING

University of Miami, Coral Gables

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

49503

RECRUITING

Corewell Health Research Institute, Grand Rapids

55905

RECRUITING

Mayo Clinic, Rochester

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

94143

RECRUITING

University of California San Francisco, San Francisco

Unknown

RECRUITING

Medical University of Vienna, Vienna

RECRUITING

University Hospitals Leuven, Leuven

RECRUITING

Hospital Universitario Puerta de Hierro-Majadahonda, Madrid

RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

RECRUITING

University Hospital Zurich, Zurich

M5G 2C4

RECRUITING

University Health Network (Toronto General Hospital), Toronto

H2X0A9

RECRUITING

Centre hospitalier de l'Université de Montréal, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical University of Vienna

OTHER

collaborator

Vanderbilt University

OTHER

collaborator

Puerta de Hierro University Hospital

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

St Vincent's Hospital, Sydney

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

Spectrum Health Hospitals

OTHER

collaborator

University of Miami

OTHER

collaborator

University Hospital of Leuven Leuven

OTHER

collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

collaborator

University Hospital, Zürich

OTHER

lead

University Health Network, Toronto

OTHER