Clinical trial NCT03639025: OCS™ Lung TOP Registry For Donor Lungs for Transplantation
Official title: The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Transplantation
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-month patient and graft survival post double-lung transplant
timeFrame: 12 months
Secondary outcomes:
measure: Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs
timeFrame: 2 hours
measure: Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)
timeFrame: 0, 24, 48 and 72 hours
measure: Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation
timeFrame: 72 hours
measure: Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate
timeFrame: 1 hour
measure: Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation
timeFrame: Within 72 hours post-transplantation
Other outcomes:
measure: Standard Criteria Lungs - Incidence of PGD3 at T72 hours
timeFrame: 72 hours
measure: Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs
timeFrame: 2 hours
measure: Kaplan-Meier patient survival estimated at Month 1, 6, 12, 24, 36, 48 and 60
timeFrame: 1,6,12,24,36,48,60 months
measure: Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60
timeFrame: 12,24,36,48,60 months
measure: Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60
timeFrame: 12,24,36,48,60 months
measure: Kaplan-Meier graft survival (freedom from re-transplant/graft failure) at Month 12, 24, 36, 48 and 60
timeFrame: 12,24,36,48,60 months
measure: Lung graft-related SAEs through 30 days post-transplant or discharge - Bronchial anastomotic complications; Major pulmonary-related infection
timeFrame: 30 days or hospital discharge (whichever is longer)
measure: Survival incidence at 30 days
timeFrame: 30 days
measure: Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days.
timeFrame: 30 days or hospital discharge (whichever is longer)
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: