Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Jasleen Kukreja, MD (ucsf)
Headshot of Jasleen Kukreja
Jasleen Kukreja

Description

Summary

Single-arm, prospective, multi-center, post-approval U.S. registry

Official Title

The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation

Details

This is an all-comers registry that will enroll:

  1. Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
  2. Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
  3. All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

  1. TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  2. TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  3. All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.

Keywords

Lung Transplantation, OCS Lung System

Eligibility

For people ages 18 years and up

This is an all-comers registry that will enroll all:

  • Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
  • Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
  • All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

  • TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  • TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  • All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Locations

  • UCLA completed
    Los Angeles California 90095 United States
  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Jasleen Kukreja, MD (ucsf)
    Dr. Jasleen Kukreja is a cardiothoracic surgeon and director of the Lung Transplant Program at UCSF Medical Center. She is also director of the adult respiratory mechanical circulatory support program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TransMedics
ID
NCT03639025
Study Type
Observational [Patient Registry]
Participants
Expecting 555 study participants
Last Updated