Lung Transplantation
Conditions
Keywords
portable ex-vivo lung perfusion, breathing lung transplant, portable OCS Lung System
Brief summary
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Detailed description
Inclusion At least one of the following: * Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or * Expected cross-clamp time \> 6 hours for the second lung; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥ 55 years old
Interventions
DEVICEOCS Lung Preservation
OCS Lung Preservation
Sponsors
TransMedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
OCS Lung System
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female primary double lung transplant candidate * Age ≥ 18 years old * Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion criteria
* Prior solid organ or bone marrow transplant * Single lung recipient * Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis * Participant in any other clinical or investigational trials/programs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | 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. |
| Donor Lung Utilization Rate | Immediately at Transplantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Graft Dysfunction Grade 3 | 72 hours post-transplant | Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Lung Graft-related Serious Adverse Events | 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. |
Countries
United States
Participant flow
Recruitment details
51 Donor Lungs were instrumented on OCS Lung and 46 Donor Lungs were accepted and transplanted on study.
Pre-assignment details
Enrollment was stopped as a result of the FDA Approval of OCS Lung for the EXPAND indication.
Participants by arm
| Arm | Count |
|---|---|
| OCS Preservation OCS Lung Preservation: OCS Lung Preservation | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 12 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Subject Discontinued Due to Re-transplant | 1 |
Baseline characteristics
| Characteristic | OCS Preservation |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 46 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 16 / 46 |
Outcome results
Primary
Donor Lung Utilization Rate
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.
Time frame: Immediately at Transplantation
Population: 51 eligible donor lungs were instrumented on OCS. 46 donor lungs were accepted after perfusion and transplanted into recipients.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| OCS Preservation | Donor Lung Utilization Rate | 46 Lungs Instrumented on OCS |
Primary
Patient Survival
Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.
Time frame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OCS Preservation | Patient Survival | 40 Participants |
Secondary
Primary Graft Dysfunction Grade 3
Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours
Time frame: 72 hours post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OCS Preservation | Primary Graft Dysfunction Grade 3 | 7 Participants |
Other Pre-specified
Number of Lung Graft-related Serious Adverse Events
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.
Time frame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OCS Preservation | Number of Lung Graft-related Serious Adverse Events | 16 Participants |