Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
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.
Device: Ex vivo lung perfusion with Steen Solution™
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs|
- 30 Day Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Mortality at 30 days post transplant.
- PGD Scores at 0,24,and 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. PGD is assessed at 0, 24 and 72 hours post operative by the Surgeon using the following scale/categories 0-1, 2, and 3, refer to Appendix III. The 72 hour assessment is analyzed as a secondary objective.
- Intensive Care Unit Stay [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Length of ICU stay post transplant
- Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days ] [ Designated as safety issue: No ]Ventilator status and extra-corporeal membrane oxygenator (ECMO) free is assessed seven days after transplant.
- 12 Month Survival [ Time Frame: 12 Months ] [ Designated as safety issue: No ]12 month subject's survival status shall be evaluated.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: EVLP Group
EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ .
Device: Ex vivo lung perfusion with Steen Solution™
The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.
Other Name: EVLP
No Intervention: Control Group
Control Group are those recipient lung transplant patients that receive donor lungs via conventional transplant.
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.
|United States, Colorado|
|University of Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Michael Weyant, MD 303-724-2800 Michael.Weyant@ucdenver.edu|
|Contact: Tracey MacDermott 303-724-2757 Tracey.MacDermott@ucdenver.edu|
|Principal Investigator: Michael Weyant, MD|
|United States, Indiana|
|Indiana University Health||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Annie Thorp, RN, BSN, CCRC 317-962-9904 email@example.com|
|Contact: Thomas Wozniak, MD 317-923-1787 TWozniak@IUHealth.org|
|Principal Investigator: Thomas Wozniak, MD|
|United States, Maryland|
|University of Maryland||Recruiting|
|Balitmore, Maryland, United States, 21201|
|Contact: Bartley Griffith, MD 410-328-3822 firstname.lastname@example.org|
|Contact: Dana Beach, BSN, CCRC 410-328-0993 DBeach2@smail.umaryland.edu|
|Principal Investigator: Bartley Griffith, MD|
|United States, Massachusetts|
|Brigham and Women's Hospital||Completed|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Columbia University Medical Centre||Recruiting|
|New York, New York, United States, 10032|
|Contact: Frank D'ovidio, MD 212-342-5226 email@example.com|
|Contact: Lyn Goldsmith, MA,RN,BSN,CCRC (212) 342-0261 firstname.lastname@example.org|
|Principal Investigator: Frank D'Ovidio, MD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Robert Davis, MD 919-681-4760 email@example.com|
|Contact: Earl Schwark, MS 919-681-5775 firstname.lastname@example.org|
|Principal Investigator: Robert Davis, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Edward Cantu, MD 215-615-6582 Edward.Cantu@uphs.upenn.edu|
|Contact: Jaya Tiwari 215-834-6525 Jaya.Tiwari@uphs.upenn.edu|
|Principal Investigator: Edward Cantu, MD|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Linda Harrison, RN 206-224-3341 email@example.com|
|Contact: Michael Mulligan, MD firstname.lastname@example.org|
|Principal Investigator: Michael Mulligan, MD|