OCS™ Lung TOP Registry For Donor Lungs for Transplantation

Lung Transplantation Clinical Trial

— TOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03639025
• Other study ID #: OCS-LUN-PAS01
• Status: Recruiting
• Start date: December 10, 2018
• Est. completion date: August 30, 2030

Study information

• Verified date: April 2024
• Source: TransMedics
• Contact: Julia Deane
• Phone: 9782893546
• Email: jdeane[@]transmedics.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 555
• Est. completion date: August 30, 2030
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Emory	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	Houston Methodist	Houston	Texas
United States	UCLA	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University	Palo Alto	California
United States	Temple University	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	UCSF	San Francisco	California
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standard Criteria Lungs - Incidence of PGD3 at T72 hours	Primary Graft Dysfunction	72 hours
Other	Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs	Ischemic and cross-clamp times	2 hours
Other	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
Other	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
Other	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
Other	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
Other	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)
Other	Survival incidence at 30 days	Safety Endpoint	30 days
Other	Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days.	Safety Endpoint	30 days or hospital discharge (whichever is longer)
Primary	12-month patient and graft survival post double-lung transplant	Primary Effectiveness Endpoint	12 months
Secondary	Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs	Lung ischemic time	2 hours
Secondary	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
Secondary	Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation	Primary Graft Dysfunction	72 hours
Secondary	Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate	Utilization Rate	1 hour
Secondary	Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation	Primary Graft Dysfunction	Within 72 hours post-transplantation