Lung Transplant
Conditions
Keywords
lung transplantation, lung preservation, breathing lung transplant
Brief summary
To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Detailed description
The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics: * Donor PaO2/FiO2 ≤ 300 mmHg; or * Expected ischemic time \> 6 hours; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥55 years old
Interventions
DEVICEOCS Lung Preservation
Sponsors
TransMedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* At least one of the following: * Donor PaO2/FiO2 ≤ 300 mmHg; or * Expected ischemic time \> 6 hours; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥55 years old
Exclusion criteria
* • Presence of moderate to severe traumatic lung injury with air and/or blood leak * Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction * Previous history of pulmonary disease * Multiple transfusions of \>10 pRBCs units * ABO incompatibility * Tobacco history of \>20 pack years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant | 30 days post lung 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation | 72 hours post lung 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. |
| Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours | 72 hours post lung 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation | 30 days post lung transplantation | 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. |
| Long-term Survival: Survival at 12-months Post-transplant | 12-months | Survival outcomes were collected through one year post-transplant. |
Countries
Belgium, Germany, Spain, United States
Participant flow
Pre-assignment details
93 donor lungs retrieved. 12 excluded for clinical reasons: 6 had contusions or open lung injury resulting in visible air and perfusate leakage into the bronchoalveolar space, 4 had unstable OCS Lung perfusion variables, and persistently low P/F ratio, 1 had persistent oedema, 1 had persistent purulent secretions. 2 were excluded for logistical reasons: 2 patients did not receive a lung transplant because of logistical reasons: 1 was diagnosed with cancer, 1 because no surgeons were available.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm OCS Lung Transplants A prospective, pivotal, international single arm trial intended to evaluate the safety and effectiveness of the OCS Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation. | 79 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
Baseline characteristics
| Characteristic | Single Arm OCS Lung Transplants |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 10.6 |
| Donor Inclusion Criteria Age ≥55 years | 22 Participants |
| Donor Inclusion Criteria DCD | 16 Participants |
| Donor Inclusion Criteria DCD and age ≥55 years | 3 Participants |
| Donor Inclusion Criteria DCD and expected cross-clamp time >6 h | 6 Participants |
| Donor Inclusion Criteria DCD and PaO2:FiO2 ≤300 mm Hg | 1 Participants |
| Donor Inclusion Criteria Expected cross-clamp time >6 h | 11 Participants |
| Donor Inclusion Criteria Expected cross-clamp time >6 h and age ≥55 years | 1 Participants |
| Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg | 9 Participants |
| Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg and age ≥55 years | 3 Participants |
| Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg and expected cross-clamp time >6 h | 5 Participants |
| Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg, expected cross-clamp time >6 h, and age ≥55 years | 2 Participants |
| Donor PaO2:FiO2 | 378 mm Hg STANDARD_DEVIATION 110 |
| Recipient BMI | 24.49 kg/m^2 STANDARD_DEVIATION 4.6 |
| Recipient Lung allocation score | 42.0 score on a scale STANDARD_DEVIATION 13.5 |
| Recipient Primary Diagnosis Bronchiectasis | 4 Participants |
| Recipient Primary Diagnosis Chronic obstructive pulmonary disease or emphysema | 27 Participants |
| Recipient Primary Diagnosis Cystic fibrosis | 12 Participants |
| Recipient Primary Diagnosis Idiopathic pulmonary fibrosis | 18 Participants |
| Recipient Primary Diagnosis Non-specific interstitial pneumonia | 5 Participants |
| Recipient Primary Diagnosis Other | 11 Participants |
| Recipient Primary Diagnosis Sarcoidosis | 2 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 46 Participants |
| Total cross-clamp time | 609 min STANDARD_DEVIATION 127 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 79 |
| other Total, other adverse events | 67 / 79 |
| serious Total, serious adverse events | 61 / 79 |
Outcome results
Primary
Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant
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.
Time frame: 30 days post lung transplantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm OCS Lung Transplants | Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant | 43 Participants |
p-value: 0.966395% CI: [0.428, 0.657]one-sided exact binomial test
Secondary
Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung 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.
Time frame: 72 hours post lung transplantation
Population: one patient was upgradable at T48 and T72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm OCS Lung Transplants | Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation | 13 Participants |
95% CI: [0.092, 0.268]
Secondary
Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours
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.
Time frame: 72 hours post lung transplantation
Population: one patient was ungradable at T48 and T72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm OCS Lung Transplants | Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours | 5 Participants |
95% CI: [0.021, 0.143]
Other Pre-specified
Long-term Survival: Survival at 12-months Post-transplant
Survival outcomes were collected through one year post-transplant.
Time frame: 12-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm OCS Lung Transplants | Long-term Survival: Survival at 12-months Post-transplant | 72 Participants |
Other Pre-specified
Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation
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.
Time frame: 30 days post lung transplantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm OCS Lung Transplants | Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation | 0.3 Events per participant | Standard Deviation 0.5 |
95% CI: [0.1, 0.4]