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International EXPAND Lung Pivotal Trial (EXPANDLung)

This study is currently recruiting participants.
Verified March 2016 by TransMedics
Sponsor:
ClinicalTrials.gov Identifier:
NCT01963780
First Posted: October 16, 2013
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
TransMedics
  Purpose
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 Intervention Phase
Lung Transplant Device: OCS Lung Preservation Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by TransMedics:

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

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

Estimated Enrollment: 75
Study Start Date: November 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCS Lung Tx. 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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Waleed H Hassanein, MD 978-552-0901 whassanein@transmedics.com
Contact: Tamer I Khayal, MD 978-552-0901 tkhayal@transmedics.com

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Michael A Smith, MD    602-406-4000    Michael.Smith011@DignityHealth.org   
Principal Investigator: Michael A Smith, MD         
United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Abbas Ardehali, MD    310-825-5841    AArdehali@mednet.ucla.edu   
Principal Investigator: Abbas Ardehali, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jasleen Kukreja, MD    415-353-4145    Jasleen.Kukreja@ucsfmedctr.org   
Principal Investigator: Jasleen Kukreja, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mauricio Villavicencio, MD    617-726-5608    MVillavicencio@mgh.harvard.edu   
Principal Investigator: Mauricio Villavicencio, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Gabriel Loor, MD    612-625-4941    gloor@umn.edu   
Principal Investigator: Gabriel Loor, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Yoshiya Toyoda, MD    215-707-2685    Yoshiya.Toyoda@tuhs.temple.edu   
Principal Investigator: Yoshiya Toyoda, MD         
Belgium
University of Leuven Hospital Recruiting
Leuven, Belgium, 3000
Contact: Dirk Van Raemdonck, MD, PhD    3216346823    dirk.vanraemdonck@uzleuven.be   
Principal Investigator: Drik Van Raemdonck, MD, PhD         
Germany
Hannover Medical School Recruiting
Hannover, Germany, D-300625
Contact: Gregor Warnecke, MD    011495115326590    warnecke.gregor@mh-hannover.de   
Principal Investigator: Gregor Warnecke, MD         
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
  More Information

Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT01963780     History of Changes
Other Study ID Numbers: OCS-LUN-012013
First Submitted: September 4, 2013
First Posted: October 16, 2013
Last Update Posted: March 29, 2016
Last Verified: March 2016

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