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Active, Not Recruiting

NCT Number: NCT03639025

OCS™ Lung TOP Registry For Donor Lungs for Transplantation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

Loading trial locations.

About this study

This is an all-comers registry that will enroll:

  • 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OCS Lung System

Device

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.

Primary outcomes

  1. 12-month patient and graft survival post double-lung transplant

    Time frame: 12 months

    Primary Effectiveness Endpoint

Secondary outcomes

  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 outcomes

  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 patient 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. 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)

  5. 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)

  6. Kaplan-Meier graft survival (freedom from re-transplant/graft failure) at Month 12, 24, 36, 48 and 60

    Time frame: 12,24,36,48,60 months

    Graft failure

  7. 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

  8. Survival incidence at 30 days

    Time frame: 30 days

    Safety Endpoint

  9. 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

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

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

Acronym: TOP

Important dates

Study start
2018
Primary completion
2025
Study completion
2029
First posted
Aug 20, 2018
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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