Trial Outcomes & Findings for Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility (NCT NCT03641677)
NCT ID: NCT03641677
Last Updated: 2026-09-03
Results Overview
Survival at 12 months following lung transplantation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
174 participants
Primary outcome timeframe
12 Months
Results posted on
2026-09-03
Participant Flow
Enrolled subjects were assigned at the time of lung transplantation. Subjects receiving donor lungs after ex vivo lung perfusion (EVLP) using the Centralized Lung Evaluation System (CLES) were assigned to the EVLP Group. Subjects receiving standard of care (non-EVLP) lung transplantation were assigned to the Control Group based on prespecified inclusion/exclusion criteria.
Participant milestones
| Measure |
EVLP Group
Subjects undergoing lung transplantation using donor lungs after ex vivo lung perfusion (EVLP) performed using the Centralized Lung Evaluation System (CLES). The study included adult recipients undergoing either single-lung transplantation (SLT) or double-lung transplantation (DLT).
|
Control Group
Subjects undergoing standard of care (non-EVLP) lung transplantation who were prospectively enrolled as a contemporaneous control group. Control subjects were matched to EVLP subjects by transplant center, transplant type (SLT or DLT), Lung Allocation Score Disease Diagnosis Group (LASDDG), and pre-transplant extracorporeal membrane oxygenation (ECMO) status.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
80
|
|
Overall Study
COMPLETED
|
79
|
74
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
EVLP Group
Subjects undergoing lung transplantation using donor lungs after ex vivo lung perfusion (EVLP) performed using the Centralized Lung Evaluation System (CLES). The study included adult recipients undergoing either single-lung transplantation (SLT) or double-lung transplantation (DLT).
|
Control Group
Subjects undergoing standard of care (non-EVLP) lung transplantation who were prospectively enrolled as a contemporaneous control group. Control subjects were matched to EVLP subjects by transplant center, transplant type (SLT or DLT), Lung Allocation Score Disease Diagnosis Group (LASDDG), and pre-transplant extracorporeal membrane oxygenation (ECMO) status.
|
|---|---|---|
|
Overall Study
Death
|
15
|
6
|
Baseline Characteristics
Ancillary Population Set (APS)
Baseline characteristics by cohort
| Measure |
EVLP Group
n=94 Participants
Subjects undergoing lung transplantation using donor lungs after ex vivo lung perfusion (EVLP) performed using the Centralized Lung Evaluation System (CLES). The study included adult recipients undergoing either single-lung transplantation (SLT) or double-lung transplantation (DLT).
|
Control Group
n=80 Participants
Subjects undergoing standard of care (non-EVLP) lung transplantation who were prospectively enrolled as a contemporaneous control group. Control subjects were matched to EVLP subjects by transplant center, transplant type (SLT or DLT), Lung Allocation Score Disease Diagnosis Group (LASDDG), and pre-transplant extracorporeal membrane oxygenation (ECMO) status.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 10.33 • n=136 Participants • Ancillary Population Set (APS)
|
61.6 Years
STANDARD_DEVIATION 9.92 • n=136 Participants • Ancillary Population Set (APS)
|
59.66 Years
STANDARD_DEVIATION 10.15 • n=272 Participants • Ancillary Population Set (APS)
|
|
Sex: Female, Male
Female
|
32 Participants
n=136 Participants • Ancillary Population Set (APS)
|
32 Participants
n=136 Participants • Ancillary Population Set (APS)
|
64 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Sex: Female, Male
Male
|
62 Participants
n=136 Participants • Ancillary Population Set (APS)
|
48 Participants
n=136 Participants • Ancillary Population Set (APS)
|
110 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
2 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=136 Participants • Ancillary Population Set (APS)
|
14 Participants
n=136 Participants • Ancillary Population Set (APS)
|
31 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
White
|
70 Participants
n=136 Participants • Ancillary Population Set (APS)
|
61 Participants
n=136 Participants • Ancillary Population Set (APS)
|
131 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=136 Participants • Ancillary Population Set (APS)
|
3 Participants
n=136 Participants • Ancillary Population Set (APS)
|
4 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=136 Participants • Ancillary Population Set (APS)
|
2 Participants
n=136 Participants • Ancillary Population Set (APS)
|
6 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=136 Participants • Ancillary Population Set (APS)
|
6 Participants
n=136 Participants • Ancillary Population Set (APS)
|
10 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=136 Participants • Ancillary Population Set (APS)
|
74 Participants
n=136 Participants • Ancillary Population Set (APS)
|
164 Participants
n=272 Participants • Ancillary Population Set (APS)
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=136 Participants • Ancillary Population Set (APS)
|
0 Participants
n=272 Participants • Ancillary Population Set (APS)
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Ancillary Population Set (APS), consisting of all EVLP recipients (N=94) and non-EVLP control recipients (N=80)
Survival at 12 months following lung transplantation
Outcome measures
| Measure |
EVLP Group
n=94 Participants
Subjects undergoing lung transplantation using donor lungs after ex vivo lung perfusion (EVLP) performed using the Centralized Lung Evaluation System (CLES). The study included adult recipients undergoing either single-lung transplantation (SLT) or double-lung transplantation (DLT).
|
Control Group
n=80 Participants
Subjects undergoing standard of care (non-EVLP) lung transplantation who were prospectively enrolled as a contemporaneous control group. Control subjects were matched to EVLP subjects by transplant center, transplant type (SLT or DLT), Lung Allocation Score Disease Diagnosis Group (LASDDG), and pre-transplant extracorporeal membrane oxygenation (ECMO) status.
|
|---|---|---|
|
12 Month Survival or Freedom From Mortality
|
84 Percent
Interval 75.0 to 90.8
|
92.5 Percent
Interval 84.4 to 97.2
|
Adverse Events
EVLP Group
Serious events: 77 serious events
Other events: 85 other events
Deaths: 15 deaths
Control Group
Serious events: 63 serious events
Other events: 73 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
EVLP Group
n=94 participants at risk
Subjects undergoing lung transplantation using donor lungs after ex vivo lung perfusion (EVLP) performed using the Centralized Lung Evaluation System (CLES). The study included adult recipients undergoing either single-lung transplantation (SLT) or double-lung transplantation (DLT).
|
Control Group
n=80 participants at risk
Subjects undergoing standard of care (non-EVLP) lung transplantation who were prospectively enrolled as a contemporaneous control group. Control subjects were matched to EVLP subjects by transplant center, transplant type (SLT or DLT), Lung Allocation Score Disease Diagnosis Group (LASDDG), and pre-transplant extracorporeal membrane oxygenation (ECMO) status.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
61.7%
58/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
43.8%
35/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Infections and infestations
Infections and infestations
|
43.6%
41/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
38.8%
31/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Cardiac disorders
Cardiac disorders
|
17.0%
16/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
7.5%
6/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
17.0%
16/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
22.5%
18/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Immune system disorders
Immune system disorders
|
16.0%
15/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
27.5%
22/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
13.8%
13/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
11.2%
9/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Investigations
Investigations
|
9.6%
9/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
6.2%
5/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
8.5%
8/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
3.8%
3/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Nervous system disorders
Nervous system disorders
|
7.4%
7/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
8.8%
7/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
General disorders
General disorders and administration site conditions
|
5.3%
5/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
0.00%
0/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
4.3%
4/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
7.5%
6/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Vascular disorders
Vascular disorders
|
4.3%
4/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
5.0%
4/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
3.2%
3/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
10.0%
8/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
Other adverse events
| Measure |
EVLP Group
n=94 participants at risk
Subjects undergoing lung transplantation using donor lungs after ex vivo lung perfusion (EVLP) performed using the Centralized Lung Evaluation System (CLES). The study included adult recipients undergoing either single-lung transplantation (SLT) or double-lung transplantation (DLT).
|
Control Group
n=80 participants at risk
Subjects undergoing standard of care (non-EVLP) lung transplantation who were prospectively enrolled as a contemporaneous control group. Control subjects were matched to EVLP subjects by transplant center, transplant type (SLT or DLT), Lung Allocation Score Disease Diagnosis Group (LASDDG), and pre-transplant extracorporeal membrane oxygenation (ECMO) status.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
69.1%
65/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
61.3%
49/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Infections and infestations
Infections and infestations
|
56.4%
53/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
51.2%
41/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Immune system disorders
Immune system disorders
|
36.2%
34/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
41.2%
33/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
26.6%
25/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
18.8%
15/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
22.3%
21/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
23.8%
19/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Cardiac disorders
Cardiac disorders
|
21.3%
20/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
17.5%
14/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
18.1%
17/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
23.8%
19/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Investigations
Investigations
|
18.1%
17/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
22.5%
18/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
14.9%
14/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
8.8%
7/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Nervous system disorders
Nervous system disorders
|
12.8%
12/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
15.0%
12/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
3.2%
3/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
11.2%
9/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
4.3%
4/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
10.0%
8/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
Vascular disorders
Vascular disorders
|
7.4%
7/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
8.8%
7/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
|
General disorders
General disorders and administration site conditions
|
7.4%
7/94 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
2.5%
2/80 • From transplantation through 12 months post-transplant
Adverse events are reported for the Ancillary Population Set (APS), consisting of 94 EVLP recipients and 80 non-EVLP control recipients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place