International EXPAND Lung Pivotal Trial

N/ACompletedNCT01963780

TransMedics79 enrolled

Overview

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics: * Donor PaO2/FiO2 ≤ 300 mmHg; or * Expected ischemic time \> 6 hours; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥55 years old

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Transplant

Interventions

OCS Lung PreservationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least one of the following: * Donor PaO2/FiO2 ≤ 300 mmHg; or * Expected ischemic time \> 6 hours; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥55 years old Exclusion Criteria: * • Presence of moderate to severe traumatic lung injury with air and/or blood leak * Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction * Previous history of pulmonary disease * Multiple transfusions of \>10 pRBCs units * ABO incompatibility * Tobacco history of \>20 pack years

Locations (11)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

University of California at Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant

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: 30 days post lung transplantation

Secondary Outcomes

Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung 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 post lung transplantation

Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours

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 post lung transplantation

Data from ClinicalTrials.gov

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