OCS™ Lung TOP Registry For Donor Lungs for Transplantation

N/AActive Not RecruitingNCT03639025

TransMedics458 enrolled

Overview

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

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

458

Conditions

Lung Transplantation

Interventions

OCS Lung SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (18)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

UCLA

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Primary Effectiveness Endpoint

Time frame: 12 months

Secondary Outcomes

Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs

Lung ischemic time

Time frame: 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

Time frame: 0, 24, 48 and 72 hours

Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation

Primary Graft Dysfunction

Time frame: 72 hours

Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate

Utilization Rate

Time frame: 1 hour

Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation

Primary Graft Dysfunction

Time frame: Within 72 hours post-transplantation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.