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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01963780
Other study ID # OCS-LUN-012013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date April 2018

Study information

Verified date April 2018
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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