International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation

TransMedics320 enrolled

Overview

A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Lung Preservation

Interventions

OCS LungDEVICE

OCS Lung will be used to preserve the donor lungs (Treatment Group).

Cold flush and storageDEVICE

Donor lungs will preserved using standard cold flush and storage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Registered primary double-lung transplant candidate * Age \> or equal to 18 * Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information Exclusion Criteria: * Prior solid organ or bone marrow transplant * Single lung recipient * Multiple organ transplant recipient * Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Locations (21)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

University of California at Los Angeles

Outcomes

Primary Outcomes

A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation.

This composite is a single outcome measure. Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

Time frame: Day 30 after transplantation

Secondary Outcomes

Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation

Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

Time frame: 72 hours after transplantation

Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation

Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

Time frame: 72 hours after transplantation

Patient Survival at Day 30

Time frame: Day 30

Data from ClinicalTrials.gov

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