International EXPAND Lung Pivotal Trial

Not Applicable

Completed

• Conditions: Lung Transplant
• Interventions: Device: OCS Lung Preservation

• Registration Number: NCT01963780
• Lead Sponsor: TransMedics

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Start: 2013-11
• Primary Completion: 2016-11-22
• Status Verified: 2018-04
• Study Completion: 2018-04
• Results First Submitted: 2022-04-06
• Results First Submitted QC: 2022-06-10
• Last Update Submitted: 2022-06-10
• Results First Posted: 2022-07-07
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCS Lung Tx.	OCS Lung Preservation	A prospective, pivotal single arm trial.

Primary Outcome Measures

Name	Time	Method
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	30 days 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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation	72 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.
Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours	72 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.

Trial Locations

Locations (11)

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Emory; 🇺🇸 Atlanta, Georgia, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Hannover Medical School; 🇩🇪 Hannover, Germany

Hospital Universitario Puerta De Hierro; 🇪🇸 Madrid, Spain

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Leuven Hospital; 🇧🇪 Leuven, Belgium