Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
- Conditions
- Lung Transplant
- Interventions
- Device: XPS™ with Steen Solution™
- Registration Number
- NCT01365429
- Lead Sponsor
- XVIVO Perfusion
- Brief Summary
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.
- Detailed Description
These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment \> 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate \>10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 252
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EVLP Group XPS™ with Steen Solution™ EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the XPS™ with Steen Solution™ and undergone ex-vivo lung perfusion before being transplanted.
- Primary Outcome Measures
Name Time Method PAS Study Primary Endpoint 3 Years The primary end point is a co-primary endpoint comparing survival rates and rates of grade 3 PGD at 72 hours with success if and only if both endpoints are met.
Treatment Group (T) = EVLP transplant subjects Control Group (C) = standard transplant subjects
Co-Primary Endpoints:
Endpoint #1: Survival of T is non-inferior to C Ho: C - T ≥ M1 (T is inferior to the control by M1 or more) Ha: C - T \< M1 (T is inferior to the control by less than M1) where M1 = 0.12 Endpoint #2: Rate of grade 3 PGD at 72 hours for T is non-inferior to the rate for C Ho: C - T ≥ M2 Ha: C - T \< M2 where M2 = 0.12PMA Study Primary Endpoint 72hrs and Survival The primary end point is non-inferiority of the 3-year survival rate of the EVLP group as compared to 3-year survival rate of the control group.
Ho: C - T ≥ M3 (T is inferior to the control by M3 or more) Ha: C - T \< M3 (T is inferior to the control by less than M3) where M3 = 0.12
- Secondary Outcome Measures
Name Time Method PMA Secondary Endpoints 3 Years Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity The PMA secondary endpoints are as follows:
* FEV1 at 3 mos, 6 mos, 9 mos, and 1 yr
* PGD score at 24 and 48 hrs
* ICU LOS
* Hospital LOS
* Use of ECMO due to lung function post transplant
* Duration of mechanical ventilation post transplant
* Quality of Life and functional status at one yearPAS Secondary Endpoint: 5 Years Quality of Life measured by functional status, physical capability, and employment limitations.
* Episodes of rejection per UNOS registry
* FEV1 at 1, 2, 3, 4, and 5 years
Trial Locations
- Locations (18)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Columbia University Medical Centre
🇺🇸New York, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Florida-Gainesville
🇺🇸Gainesville, Florida, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
Duke University
🇺🇸Durham, North Carolina, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States