International EXPAND Lung Pivotal Trial

Lung Transplant Clinical Trial

— EXPANDLung  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963780
• Other study ID #: OCS-LUN-012013
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 2018
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant

Intervention

Device:
• OCS Lung Preservation

Locations

Country	Name	City	State
Belgium	University of Leuven Hospital	Leuven
Germany	Hannover Medical School	Hannover
Spain	Hospital Universitario Puerta De Hierro	Madrid
United States	Emory	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University	Durham	North Carolina
United States	University of California at Los Angeles	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Long-term Survival: Survival at 12-months Post-transplant	Survival outcomes were collected through one year post-transplant.	12-months
Primary	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	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
Secondary	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