Trial Outcomes & Findings for International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation (NCT NCT01630434)

Last Updated: 2023-04-04

Results Overview

This composite is a single outcome measure. 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

320 participants

Primary outcome timeframe

Day 30 after transplantation

Results posted on

2023-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	OCS Lung (Treatment Group) The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Overall Study STARTED	151	169
Overall Study Safety Population	150	169
Overall Study Per Protocol Population	141	165
Overall Study COMPLETED	121	139
Overall Study NOT COMPLETED	30	30

Reasons for withdrawal

Reasons for withdrawal
Measure	OCS Lung (Treatment Group) The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Overall Study Donor lungs turned down	1	0
Overall Study Protocol Violation	9	4
Overall Study Death	20	26

Baseline Characteristics

International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OCS Lung (Treatment Group) n=151 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	Total n=320 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 13.1 • n=93 Participants	50.0 years STANDARD_DEVIATION 13.6 • n=4 Participants	50.2 years STANDARD_DEVIATION 13.3 • n=27 Participants
Sex: Female, Male Female	74 Participants n=93 Participants	63 Participants n=4 Participants	137 Participants n=27 Participants
Sex: Female, Male Male	77 Participants n=93 Participants	106 Participants n=4 Participants	183 Participants n=27 Participants
Donor Smoking History in Past 6 Months	27 Participants n=93 Participants	27 Participants n=4 Participants	54 Participants n=27 Participants
Final PaO2:FiO2 (mm Hg)	438.5 mm Hg STANDARD_DEVIATION 80.0 • n=93 Participants	431.7 mm Hg STANDARD_DEVIATION 73.8 • n=4 Participants	434.9 mm Hg STANDARD_DEVIATION 76.7 • n=27 Participants
Recipient Transplant Indication COPD	46 Participants n=93 Participants	52 Participants n=4 Participants	98 Participants n=27 Participants
Recipient Transplant Indication Pulmonary Fibrosis	49 Participants n=93 Participants	57 Participants n=4 Participants	106 Participants n=27 Participants
Recipient Transplant Indication Cystic Fibrosis	31 Participants n=93 Participants	40 Participants n=4 Participants	71 Participants n=27 Participants
Recipient Transplant Indication Idiopathic Pulmonary Hypertension	13 Participants n=93 Participants	6 Participants n=4 Participants	19 Participants n=27 Participants
Recipient Transplant Indication Sarcoidosis	4 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants
Recipient Transplant Indication Other	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Recipient Lung Allocation Score	50.8 score on a scale STANDARD_DEVIATION 20.9 • n=93 Participants	47.9 score on a scale STANDARD_DEVIATION 18.7 • n=4 Participants	49.3 score on a scale STANDARD_DEVIATION 19.8 • n=27 Participants
Recipient BMI	23.2 kg/m^2 STANDARD_DEVIATION 4.6 • n=93 Participants	23.0 kg/m^2 STANDARD_DEVIATION 4.1 • n=4 Participants	23.1 kg/m^2 STANDARD_DEVIATION 4.3 • n=27 Participants

PRIMARY outcome

Timeframe: Day 30 after transplantation

Outcome measures

Outcome measures
Measure	OCS Lung (Treatment Group) - Per Protocol n=141 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - Per Protocol n=165 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	OCS Lung (Treatment Group) - ITT n=151 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - ITT n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation.	112 Participants	116 Participants	112 Participants	119 Participants

SECONDARY outcome

Timeframe: 72 hours after 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.

Outcome measures

Outcome measures
Measure	OCS Lung (Treatment Group) - Per Protocol n=141 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - Per Protocol n=165 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	OCS Lung (Treatment Group) - ITT n=151 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - ITT n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation	3 Participants	6 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 72 hours after 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.

Outcome measures

Outcome measures
Measure	OCS Lung (Treatment Group) - Per Protocol n=141 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - Per Protocol n=165 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	OCS Lung (Treatment Group) - ITT n=151 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - ITT n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation	16 Participants	13 Participants	22 Participants	14 Participants

SECONDARY outcome

Timeframe: Day 30

Outcome measures

Outcome measures
Measure	OCS Lung (Treatment Group) - Per Protocol n=141 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - Per Protocol n=165 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	OCS Lung (Treatment Group) - ITT n=151 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - ITT n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Patient Survival at Day 30	135 Participants	165 Participants	142 Participants	168 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days post-transplant

Population: This analysis was done on the safety population.

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.

Outcome measures

Outcome measures
Measure	OCS Lung (Treatment Group) - Per Protocol n=150 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - Per Protocol n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	OCS Lung (Treatment Group) - ITT The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - ITT Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject	0.23 events per participant Interval 0.0 to 0.47	0.28 events per participant Interval 0.0 to 0.47	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	OCS Lung (Treatment Group) - Per Protocol n=141 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - Per Protocol n=165 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage	OCS Lung (Treatment Group) - ITT n=151 Participants The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) - ITT n=169 Participants Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Long-term Survival: 24-month Survival	121 Participants	139 Participants	127 Participants	142 Participants

Adverse Events

OCS Lung (Treatment Group)

Serious events: 83 serious events

Other events: 125 other events

Deaths: 24 deaths

Cold Flush and Storage (Control Group)

Serious events: 107 serious events

Other events: 141 other events

Deaths: 27 deaths

Serious adverse events

Other adverse events

Additional Information

VP, Clinical Affairs

TransMedics, Inc.

Phone: 978.552.0900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Site shall have right to publish results. To balance this right with TransMedics' (TM) proprietary interests, site will submit manuscripts intended for publication for TM's review at least 60d prior to submission date. TM will complete its review within 60d of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request. After 60d period, site will have right to publish manuscript, as amended by TM.
Publication restrictions are in place

Restriction type: OTHER

Measure	OCS Lung (Treatment Group) n=150 participants at risk The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) n=169 participants at risk Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	28.0% 42/150 • Number of events 54 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	30.2% 51/169 • Number of events 66 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Infections and infestations Infections and infestations	20.7% 31/150 • Number of events 36 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	29.6% 50/169 • Number of events 65 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Cardiac disorders Cardiac disorders	10.0% 15/150 • Number of events 20 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	8.9% 15/169 • Number of events 16 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Renal and urinary disorders Renal and urinary disorders	7.3% 11/150 • Number of events 11 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	7.1% 12/169 • Number of events 12 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Vascular disorders Vascular disorders	7.3% 11/150 • Number of events 14 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	4.1% 7/169 • Number of events 7 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	7.3% 11/150 • Number of events 11 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	5.3% 9/169 • Number of events 9 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Gastrointestinal disorders Gastrointestinal disorders	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	7.1% 12/169 • Number of events 16 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Immune system disorders Immune system disorders	4.0% 6/150 • Number of events 6 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	7.1% 12/169 • Number of events 12 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Nervous system disorders Nervous system disorders	5.3% 8/150 • Number of events 9 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	4.1% 7/169 • Number of events 7 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
General disorders General disorders and administration site conditions	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	3.0% 5/169 • Number of events 5 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Psychiatric disorders Psychiatric disorders	0.00% 0/150 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	2.4% 4/169 • Number of events 4 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.59% 1/169 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	1.2% 2/169 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/150 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.59% 1/169 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Surgical and medical procedures Surgical and medical procedures	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Congenital, familial and genetic disorders Congenital, familial and genetic disorders	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Investigations Investigations	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).

Measure	OCS Lung (Treatment Group) n=150 participants at risk The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group).	Cold Flush and Storage (Control Group) n=169 participants at risk Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	37.3% 56/150 • Number of events 79 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	40.8% 69/169 • Number of events 95 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Infections and infestations Infections and infestations	28.0% 42/150 • Number of events 52 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	32.0% 54/169 • Number of events 72 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Cardiac disorders Cardiac disorders	22.0% 33/150 • Number of events 39 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	27.2% 46/169 • Number of events 48 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Renal and urinary disorders Renal and urinary disorders	12.0% 18/150 • Number of events 18 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	14.8% 25/169 • Number of events 25 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Vascular disorders Vascular disorders	12.0% 18/150 • Number of events 22 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	7.1% 12/169 • Number of events 12 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	11.3% 17/150 • Number of events 18 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	10.7% 18/169 • Number of events 18 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Gastrointestinal disorders Gastrointestinal disorders	5.3% 8/150 • Number of events 8 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	10.7% 18/169 • Number of events 25 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Immune system disorders Immune system disorders	14.7% 22/150 • Number of events 23 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	18.9% 32/169 • Number of events 36 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Nervous system disorders Nervous system disorders	14.0% 21/150 • Number of events 22 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	8.3% 14/169 • Number of events 15 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
General disorders General disorders and administration site conditions	3.3% 5/150 • Number of events 7 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	5.3% 9/169 • Number of events 9 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Psychiatric disorders Psychiatric disorders	4.7% 7/150 • Number of events 7 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	5.9% 10/169 • Number of events 10 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Blood and lymphatic system disorders Blood and lymphatic system disorders	2.7% 4/150 • Number of events 5 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	4.1% 7/169 • Number of events 7 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Metabolism and nutrition disorders Metabolism and nutrition disorders	4.7% 7/150 • Number of events 7 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	4.1% 7/169 • Number of events 8 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/150 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.59% 1/169 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Surgical and medical procedures Surgical and medical procedures	1.3% 2/150 • Number of events 3 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	1.2% 2/169 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Congenital, familial and genetic disorders Congenital, familial and genetic disorders	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Investigations Investigations	3.3% 5/150 • Number of events 5 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	8.3% 14/169 • Number of events 15 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.59% 1/169 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Endocrine disorders Endocrine disorders	0.00% 0/150 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	1.2% 2/169 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Eye disorders Eye disorders	1.3% 2/150 • Number of events 2 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
Ear and labyrinth disorders Ear and labyrinth disorders	0.67% 1/150 • Number of events 1 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).	0.00% 0/169 • Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant. The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).