Trial Outcomes & Findings for International EXPAND Lung Pivotal Trial (NCT NCT01963780)

NCT ID: NCT01963780

Last Updated: 2022-07-07

Results Overview

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: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: 30 days post lung transplantation
• Results posted on: 2022-07-07

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	79
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	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.
Overall Study Death	7

Baseline Characteristics

Data not available for all recipients

Baseline characteristics by cohort

Measure	Single Arm OCS Lung Transplants n=79 Participants 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.
Age, Continuous	47 years STANDARD_DEVIATION 16 • n=79 Participants
Sex: Female, Male Female	33 Participants n=79 Participants
Sex: Female, Male Male	46 Participants n=79 Participants
Donor Inclusion Criteria Age ≥55 years	22 Participants n=79 Participants
Donor Inclusion Criteria DCD	16 Participants n=79 Participants
Donor Inclusion Criteria Expected cross-clamp time >6 h	11 Participants n=79 Participants
Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg	9 Participants n=79 Participants
Donor Inclusion Criteria DCD and expected cross-clamp time >6 h	6 Participants n=79 Participants
Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg and expected cross-clamp time >6 h	5 Participants n=79 Participants
Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg and age ≥55 years	3 Participants n=79 Participants
Donor Inclusion Criteria DCD and age ≥55 years	3 Participants n=79 Participants
Donor Inclusion Criteria DCD and PaO2:FiO2 ≤300 mm Hg	1 Participants n=79 Participants
Donor Inclusion Criteria Expected cross-clamp time >6 h and age ≥55 years	1 Participants n=79 Participants
Donor Inclusion Criteria PaO2:FiO2 ≤300 mm Hg, expected cross-clamp time >6 h, and age ≥55 years	2 Participants n=79 Participants
Donor PaO2:FiO2	378 mm Hg STANDARD_DEVIATION 110 • n=79 Participants
Total cross-clamp time	609 min STANDARD_DEVIATION 127 • n=79 Participants
Recipient BMI	24.49 kg/m^2 STANDARD_DEVIATION 4.6 • n=79 Participants
Recipient Lung allocation score	42.0 score on a scale STANDARD_DEVIATION 13.5 • n=70 Participants • Data not available for all recipients
Recipient Primary Diagnosis Chronic obstructive pulmonary disease or emphysema	27 Participants n=79 Participants
Recipient Primary Diagnosis Idiopathic pulmonary fibrosis	18 Participants n=79 Participants
Recipient Primary Diagnosis Cystic fibrosis	12 Participants n=79 Participants
Recipient Primary Diagnosis Non-specific interstitial pneumonia	5 Participants n=79 Participants
Recipient Primary Diagnosis Bronchiectasis	4 Participants n=79 Participants
Recipient Primary Diagnosis Sarcoidosis	2 Participants n=79 Participants
Recipient Primary Diagnosis Other	11 Participants n=79 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Arm OCS Lung Transplants n=79 Participants 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.
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

SECONDARY outcome

Timeframe: 72 hours post lung transplantation

Population: one patient was upgradable at T48 and T72

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

Measure	Single Arm OCS Lung Transplants n=78 Participants 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.
Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation	13 Participants

SECONDARY outcome

Timeframe: 72 hours post lung transplantation

Population: one patient was ungradable at T48 and T72

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

Measure	Single Arm OCS Lung Transplants n=78 Participants 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.
Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Single Arm OCS Lung Transplants n=79 Participants 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.
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

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-months

Survival outcomes were collected through one year post-transplant.

Outcome measures

Measure	Single Arm OCS Lung Transplants n=79 Participants 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.
Long-term Survival: Survival at 12-months Post-transplant	72 Participants

Adverse Events

Single Arm OCS Lung Transplants

Serious events: 61 serious events

Other events: 67 other events

Deaths: 7 deaths

Serious adverse events

Measure	Single Arm OCS Lung Transplants n=79 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	35.4% 28/79 • Number of events 31 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Infections and infestations Infections and infestations	34.2% 27/79 • Number of events 38 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Cardiac disorders Cardiac disorders	11.4% 9/79 • Number of events 9 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Renal and urinary disorders Renal and urinary disorders	5.1% 4/79 • Number of events 4 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Vascular disorders Vascular disorders	5.1% 4/79 • Number of events 4 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	20.3% 16/79 • Number of events 18 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Gastrointestinal disorders Gastrointestinal disorders	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Immune system disorders Immune system disorders	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Nervous system disorders Nervous system disorders	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
General disorders General disorders and administration site conditions	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Psychiatric disorders Psychiatric disorders	7.6% 6/79 • Number of events 6 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Metabolism and nutrition disorders Metabolism and nutrition disorders	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Hepatobiliary disorders Hepatobiliary disorders	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Investigations Investigations	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.

Other adverse events

Measure	Single Arm OCS Lung Transplants n=79 participants at risk 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.
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Cardiac disorders Cardiac disorders	25.3% 20/79 • Number of events 20 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Endocrine disorders Endocrine disorders	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Gastrointestinal disorders Gastrointestinal disorders	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
General disorders General disorders and administration site conditions	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Hepatobiliary disorders Hepatobiliary disorders	1.3% 1/79 • Number of events 1 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Immune system disorders Immune system disorders	12.7% 10/79 • Number of events 10 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	24.1% 19/79 • Number of events 21 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Investigations Investigations	5.1% 4/79 • Number of events 4 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Metabolism and nutrition disorders Metabolism and nutrition disorders	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	2.5% 2/79 • Number of events 2 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Nervous system disorders Nervous system disorders	3.8% 3/79 • Number of events 3 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Psychiatric disorders Psychiatric disorders	7.6% 6/79 • Number of events 6 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Renal and urinary disorders Renal and urinary disorders	10.1% 8/79 • Number of events 8 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	41.8% 33/79 • Number of events 39 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Vascular disorders Vascular disorders	5.1% 4/79 • Number of events 4 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.
Infections and infestations Infections and infestations	35.4% 28/79 • Number of events 28 • Adverse events were collected for 30 days post-transplant. Serious adverse events were collected for 30 days post-transplant or through hospital discharge, if longer than 30 days. All-cause mortality was collected for the first 12 months post transplant. Serious adverse events were collected through regular investigator assessment and/or regular laboratory testing.

Additional Information

VP, Clinical Affairs

TransMedics, Inc.

Phone: 978.552.0900

Email: ldamme@transmedics.com

Results disclosure agreements

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Restriction type: OTHER