International EXPAND Lung Pivotal Trial (EXPANDLung)

International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant
• Intervention / Treatment: Device: OCS Lung Preservation

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University of Leuven Hospital
• Germany
  • Hannover, Germany, D-300625
    • Hannover Medical School
• Spain
  • Madrid, Spain, 25222
    • Hospital Universitario Puerta de Hierro
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
  • California
    • Los Angeles, California, United States, 90095
      • University of California at Los Angeles
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OCS Lung Tx.; A prospective, pivotal single arm trial.	Device: OCS Lung Preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post lung transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	72 hours post lung transplantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation	An LGRSAE event is defined as the occurrence of any of the following four categories of adverse events that are also serious; acute rejection, respiratory failure, bronchial anastomotic complication, and major pulmonary-related infection.	30 days post lung transplantation
Long-term Survival: Survival at 12-months Post-transplant	Survival outcomes were collected through one year post-transplant.	12-months

Collaborators and Investigators

• Sponsor: TransMedics
• Investigators: Principal Investigator: Abbas Ardehali, MD, University of California, Los Angeles; Principal Investigator: Dirk Van Raemdonck, MD, PhD, University of Leuven Medical Center

Publications and helpful links

General Publications

• Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): November 22, 2016
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (ESTIMATE): October 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: lung transplantation; lung preservation; breathing lung transplant
• Other Study ID Numbers: OCS-LUN-012013