OCS™ Lung TOP Registry For Donor Lungs for Transplantation (TOP)

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

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

Study Overview

• Status: Recruiting
• Conditions: Lung Transplantation
• Intervention / Treatment: Device: OCS Lung System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 555

Contacts and Locations

• Study Contact: Name: Julia Deane; Phone Number: 9782893546; Email: jdeane@transmedics.com
• Study Contact Backup: Name: Kausar Qidwai; Phone Number: 9785220984; Email: kqidwai@transmedics.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • St. Joseph's Hospital and Medical Center
      • Principal Investigator: Michael A Smith, MD
      • Contact: Noor Elkurwi, MD; Phone Number: 602-406-5853; Email: noor.elkurwi@commonspirit.org
  • California
    • Los Angeles, California, United States, 90095
      • Completed
      • UCLA
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Tiffany Kimiko Koyano; Email: tkoyano3@stanford.edu
      • Principal Investigator: Anson M Lee, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF
      • Principal Investigator: Jasleen Kukreja, MD
      • Contact: Sahand Hassanipour; Email: sahand.hassanipour@ucsf.edu
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Courtney Nicholas; Phone Number: 813-844-4914; Email: coutneynicholas@tgh.org
      • Principal Investigator: Kapilkumar Patel, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory
      • Contact: Jeryl Huckaby, RN; Email: jhuckab@emory.edu
      • Principal Investigator: Joshua Chan, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Principal Investigator: Christopher Salerno, MD
      • Contact: Kayla Moore; Email: kaymoore@bsd.uchicago.edu
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Johns Hopkins
      • Contact: Errol Bush, MD; Email: errol.bush@jhu.edu
      • Principal Investigator: Errol Bush, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Nathaniel Langer, MD; Phone Number: 617-726-2593; Email: nlanger@partners.org
      • Principal Investigator: Nathaniel Langer, MD
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Contact: Hassan Nemeh, MD; Phone Number: 313-916-2600; Email: hnemeh1@hfhs.org
      • Principal Investigator: Hassan Nemeh, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Nick Lemke; Email: ntlemke@umn.edu
      • Principal Investigator: Stephen Huddleston, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • Nebraska Medical Center
      • Principal Investigator: Aleem Siddique, MD
      • Contact: Dawn Gunzenhauser; Email: dgunzenhauser@unmc.edu
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore
      • Contact: Magdalena Mamczur-Madry, RN, BSN, MS; Phone Number: 718-920-3576; Email: mmamczur@montefiore.org
      • Principal Investigator: Stephen Forest, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Kathleen Lane, BSN, RN; Email: kathleen.rohrback@duke.edu
      • Principal Investigator: Matthew G Hartwig, MD, MHS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Contact: Patricia McNelis; Phone Number: 267-541-0813; Email: patricia.mcnelis@tuhs.temple.edu
      • Principal Investigator: Yoshiya Toyoda, MD, PhD
  • Texas
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Scott & White Research Institute
      • Principal Investigator: Gary Schwartz, MD
      • Contact: Victoria Adams; Email: victoria.adams@BSWHealth.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor St. Luke's Medical Center
      • Contact: Gabriel Loor, MD; Phone Number: 832-355-3000; Email: gabriel.loor@bcm.edu
    • Houston, Texas, United States, 77030
      • Completed
      • Houston Methodist
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Active, not recruiting
      • University of Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Kelly Potzner; Email: kpotzner@mcw.edu
      • Principal Investigator: Lucian Durham, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Other Enrolled Patients; All OCS Lung transplanted patients that do not meet any of the above analysis populations.	Device: OCS Lung System; The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: Reducing ischemic injury through the use of warm, oxygenated blood based perfusion.; Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients.; Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.
Standard Donor Lungs Primary Analysis Population; Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.	Device: OCS Lung System; The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: Reducing ischemic injury through the use of warm, oxygenated blood based perfusion.; Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients.; Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.
Donor Lungs Initially Unacceptable Primary Analysis Pop.; Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.	Device: OCS Lung System; The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: Reducing ischemic injury through the use of warm, oxygenated blood based perfusion.; Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients.; Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month patient and graft survival post double-lung transplant	Primary Effectiveness Endpoint	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs	Lung ischemic time	2 hours
Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)	Primary Graft Dysfunction	0, 24, 48 and 72 hours
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation	Primary Graft Dysfunction	72 hours
Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate	Utilization Rate	1 hour
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation	Primary Graft Dysfunction	Within 72 hours post-transplantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Criteria Lungs - Incidence of PGD3 at T72 hours	Primary Graft Dysfunction	72 hours
Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs	Ischemic and cross-clamp times	2 hours
Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60	BOS free survival (K-M)	12,24,36,48,60 months
Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60	Freedom from BOS (K-M)	12,24,36,48,60 months
Lung graft-related SAEs through 30 days post-transplant or discharge - Bronchial anastomotic complications; Major pulmonary-related infection	Safety Endpoint	30 days or hospital discharge (whichever is longer)
Survival incidence at 30 days	Safety Endpoint	30 days
Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days.	Safety Endpoint	30 days or hospital discharge (whichever is longer)
Kaplan-Meier patient survival estimated at Month 1, 6, 12, 24, 36, 48 and 60	Survival evaluation (K-M)	1,6,12,24,36,48,60 months
Kaplan-Meier graft survival (freedom from re-transplant/graft failure) at Month 12, 24, 36, 48 and 60	Graft failure	12,24,36,48,60 months

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LUN-PAS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No