Trial Outcomes & Findings for OCS Lung System EXPAND II Trial (NCT NCT03343535)

NCT ID: NCT03343535

Last Updated: 2024-02-28

Results Overview

Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
• Results posted on: 2024-02-28

Participant Flow

51 Donor Lungs were instrumented on OCS Lung and 46 Donor Lungs were accepted and transplanted on study.

Enrollment was stopped as a result of the FDA Approval of OCS Lung for the EXPAND indication.

Participant milestones

Measure	OCS Preservation OCS Lung Preservation: OCS Lung Preservation
Overall Study STARTED	46
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	OCS Preservation OCS Lung Preservation: OCS Lung Preservation
Overall Study Lost to Follow-up	1
Overall Study Subject Discontinued Due to Re-transplant	1
Overall Study Death	12

Baseline Characteristics

OCS Lung System EXPAND II Trial

Baseline characteristics by cohort

Measure	OCS Preservation n=46 Participants OCS Lung Preservation: OCS Lung Preservation
Age, Continuous	54.5 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant

Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.

Outcome measures

Measure	OCS Preservation n=46 Participants OCS Lung Preservation: OCS Lung Preservation
Patient Survival	40 Participants

PRIMARY outcome

Timeframe: Immediately at Transplantation

Population: 51 eligible donor lungs were instrumented on OCS. 46 donor lungs were accepted after perfusion and transplanted into recipients.

Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.

Outcome measures

Measure	OCS Preservation n=51 Lungs Instrumented on OCS OCS Lung Preservation: OCS Lung Preservation
Donor Lung Utilization Rate	46 Lungs Instrumented on OCS

SECONDARY outcome

Timeframe: 72 hours post-transplant

Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours

Outcome measures

Measure	OCS Preservation n=46 Participants OCS Lung Preservation: OCS Lung Preservation
Primary Graft Dysfunction Grade 3	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant

Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject.

Outcome measures

Measure	OCS Preservation n=46 Participants OCS Lung Preservation: OCS Lung Preservation
Number of Lung Graft-related Serious Adverse Events	16 Participants

Adverse Events

OCS Preservation

Serious events: 16 serious events

Other events: 0 other events

Deaths: 12 deaths

Serious adverse events

Measure	OCS Preservation n=46 participants at risk OCS Lung Preservation: OCS Lung Preservation
Respiratory, thoracic and mediastinal disorders Respiratory failure/protracted ventilation	26.1% 12/46 • Number of events 13 • Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients. Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.
Infections and infestations Major pulmonary-related infection	15.2% 7/46 • Number of events 8 • Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients. Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.
Respiratory, thoracic and mediastinal disorders Bronchial anastomotic complication	4.3% 2/46 • Number of events 2 • Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients. Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.
General disorders Biopsy-proven moderate or severe acute rejection	2.2% 1/46 • Number of events 1 • Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients. Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.

Other adverse events

Adverse event data not reported

Additional Information

VP, Clinical Affairs

TransMedics, Inc.

Phone: 978-552-0900

Email: ldamme@transmedics.com

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 30d prior to submission date. TM will complete its review within 30d 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