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

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ClinicalTrials.gov Identifier: NCT03639025
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
TransMedics

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Single-arm, prospective, multi-center, post-approval U.S. registry

Condition or disease Intervention/treatment
Lung Transplantation Device: OCS Lung System

Detailed Description:

This is an all-comers registry that will enroll:

  1. Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
  2. Consented 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 the first 289 eligible/PAS consented 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 the first 266 eligible/PAS consented 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 both the 289 Primary Analysis Population for OCS-preserved standard criteria donor lungs and 266 Primary Analysis Population for OCS-preserved donor lungs initially deemed unacceptable have been completed.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 555 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Standard Donor Lungs Primary Analysis Population
The first 289 eligible/PAS consented 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.
Initially Unacceptable Donor Lung Primary Analysis Pop.
The first 266 eligible/PAS consented 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 12-month patient and graft survival post double-lung transplant [ Time Frame: 12 months ]
    Primary Effectiveness Endpoint


Secondary Outcome Measures :
  1. Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs [ Time Frame: 2 hours ]
    Lung ischemic time

  2. Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours) [ Time Frame: 0, 24, 48 and 72 hours ]
    Primary Graft Dysfunction

  3. Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation [ Time Frame: 72 hours ]
    Primary Graft Dysfunction

  4. Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate [ Time Frame: 1 hour ]
    Utilization Rate

  5. Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation [ Time Frame: Within 72 hours post-transplantation ]
    Primary Graft Dysfunction


Other Outcome Measures:
  1. Standard Criteria Lungs - Incidence of PGD3 at T72 hours [ Time Frame: 72 hours ]
    Primary Graft Dysfunction

  2. Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs [ Time Frame: 2 hours ]
    Ischemic and cross-clamp times

  3. Kaplan-Meier survival estimated at Month 1, 6, 12, 24, 36, 48 and 60 [ Time Frame: 1,6,12,24,36,48,60 months ]
    Survival evaluation (K-M)

  4. Survival incidence at Month 6, 12, 24, 36, 48 and 60 [ Time Frame: 6,12,24,36,48,60 months ]
    Survival incidence (simple proportion)

  5. Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]
    BOS free survival (K-M)

  6. Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]
    Freedom from BOS (K-M)

  7. Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]
    BOS Incidence (simple proportion)

  8. Incidence of re-transplantation (graft failure) at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]
    Graft failure

  9. Kaplan-Meier transplantation-free survival estimated at Month 12, 24, 36, 48 and 60 [ Time Frame: 12,24,36,48,60 months ]
    Graft failure

  10. Lung graft-related SAEs through 30 days post-transplant or discharge - Bronchial anastomotic complications; Major pulmonary-related infection [ Time Frame: 30 days or hospital discharge (whichever is longer) ]
    Safety Endpoint

  11. Survival incidence at 30 days [ Time Frame: 30 days ]
    Safety Endpoint

  12. Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days. [ Time Frame: 30 days or hospital discharge (whichever is longer) ]
    Safety Endpoint


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System
Criteria

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

  • Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
  • Consented 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 the first 289 eligible/PAS consented 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 the first 266 eligible/PAS consented 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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639025


Contacts
Layout table for location contacts
Contact: Kausar Qidwai 9785220984 kqidwai@transmedics.com

Locations
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Sponsors and Collaborators
TransMedics
More Information
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Additional Information:

Layout table for additonal information
Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT03639025    
Other Study ID Numbers: OCS-LUN-PAS01
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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