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Clinical Trials/NCT03639025
NCT03639025Active, not recruitingNot Applicable

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

TransMedics18 sites in 1 country458 target enrollmentStarted: December 10, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
458
Locations
18
Primary Endpoint
12-month patient and graft survival post double-lung transplant
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Primary Effectiveness Endpoint

Secondary Outcomes

  • Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation(72 hours)
  • Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs(2 hours)
  • Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation(Within 72 hours post-transplantation)
  • Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)(0, 24, 48 and 72 hours)
  • Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate(1 hour)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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