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International EXPAND Lung Pivotal Trial (EXPANDLung)

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ClinicalTrials.gov Identifier: NCT01963780
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Transplant Device: OCS Lung Preservation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2013
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCS Lung Tx. Device: OCS Lung Preservation



Primary Outcome Measures :
  1. 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 [ Time Frame: 30 days ]
    The COMPOSITE incidence of patient survival at day-30 post transplant and freedom of Primary Graft Dysfunction Grade 3 during the first 72 hours after lung transplantation


Secondary Outcome Measures :
  1. Incidence of ISHLT primary graft dysfunction (PGD) Grade 2 or 3 at T72 hours post lung transplantation [ Time Frame: 72 hours ]
  2. Incidence of Primary Graft Dysfunction Grade 3 at T72 hours [ Time Frame: 72 hours ]

Other Outcome Measures:
  1. Incidence of Lung Graft Related Serious Adverse Events during the first 30 days post lung transplantation [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963780


Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Belgium
University of Leuven Hospital
Leuven, Belgium, 3000
Germany
Hannover Medical School
Hannover, Germany, D-300625
Sponsors and Collaborators
TransMedics
Investigators
Principal Investigator: Abbas Ardehali, MD University of California, Los Angeles
Principal Investigator: Dirk Van Raemdonck, MD, PhD University of Leuven Medical Center

Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT01963780     History of Changes
Other Study ID Numbers: OCS-LUN-012013
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: April 2018

Keywords provided by TransMedics:
lung transplantation
lung preservation
breathing lung transplant