Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
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|ClinicalTrials.gov Identifier: NCT01365429|
Recruitment Status : Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplant||Device: XPS™ with Steen Solution™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||252 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2020|
Experimental: EVLP Group
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.
Device: XPS™ with Steen Solution™
The XPS™ System is an integrated cardiac bypass system comprised of various components such as a Maquet CardioHelp centrifugal pump (K102726), the HicoVariotherm Heater/Cooler, the Hamilton C2 ICU (intensive care unit) pressure- controlled ventilator (K092148), the perfusate gas monitors, and the display monitors. The XPS™ System is responsible for housing the organ for preservation, providing the normothermic environment, and perfusing the organ with the STEEN Solution™. Donor lungs that meet inclusion criteria are placed on the XPS™ and rewarmed and perfused with STEEN Solution™ and ventilated for 3-6 hours. If the lungs meet transplant suitability, they are cooled down and transplanted into a consented recipient that meet's trial criteria.
No Intervention: Control Group
Control Group are those recipient lung transplant patients that receive donor lungs via conventional transplant.
- PAS Study Primary Endpoint [ Time Frame: 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
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 = 0.12
- PMA Study Primary Endpoint [ Time Frame: 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
- PMA Secondary Endpoints [ Time Frame: 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 year
- PAS Secondary Endpoint: [ Time Frame: 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
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): NCT01365429
|Study Director:||Jaya Tiwari, BS, CCRP||XVIVO Perfusion, Inc|