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To evaluate the safety and effectiveness of the OCSâ„¢ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
The OCSâ„¢ 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Lung Tx. | Experimental | A prospective, pivotal single arm trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Lung Preservation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post lung transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours post lung transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post lung transplantation |
Inclusion Criteria:
At least one of the following:
Exclusion Criteria:
• Presence of moderate to severe traumatic lung injury with air and/or blood leak
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| Name | Affiliation | Role |
|---|---|---|
| Abbas Ardehali, MD | University of California, Los Angeles | Principal Investigator |
| Dirk Van Raemdonck, MD, PhD | University of Leuven Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| University of California at Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31378427 | Derived | Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Recipient Age (years) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30 days post lung transplantation |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Affairs | TransMedics, Inc. | 978.552.0900 | ldamme@transmedics.com |
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| 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. | 72 hours post lung transplantation |
| Long-term Survival: Survival at 12-months Post-transplant | Survival outcomes were collected through one year post-transplant. | 12-months |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Emory | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Leuven Hospital | Leuven | 3000 | Belgium |
| Hannover Medical School | Hanover | D-300625 | Germany |
| Hospital Universitario Puerta De Hierro | Madrid | 25222 | Spain |
| Standard Deviation |
| years |
|
| Age, Continuous | Donor Age (years) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Recipient Sex (Male/Female) | Count of Participants | Participants |
|
| Sex: Female, Male | Donor Sex (Male/Female) | Count of Participants | Participants |
|
| Donor Inclusion Criteria | Donor inclusion criteria are defined as age ≥55 years, DCD, expected cross-clamp time >6 hours, or PaO2:FiO2 ≤300 mm Hg. | Count of Participants | Participants |
|
| Donor PaO2:FiO2 | Clinical laboratory value used to assess oxygen status | Mean | Standard Deviation | mm Hg |
|
| Total cross-clamp time | Mean | Standard Deviation | min |
|
| Recipient BMI | Mean | Standard Deviation | kg/m^2 |
|
| Recipient Lung allocation score | Recipient lung allocation score (LAS) is the value that determines a recipient's urgency on the waitlist. This score is assigned on a scale of 0 to 100, 0 being the least urgent and 100 being the most urgent recipient. | Data not available for all recipients | Mean | Standard Deviation | score on a scale |
|
| Recipient Primary Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | one patient was upgradable at T48 and T72 | Posted | Count of Participants | Participants | 72 hours post lung transplantation |
|
|
|
|
| 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. | one patient was ungradable at T48 and T72 | Posted | Count of Participants | Participants | 72 hours post lung transplantation |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Events per participant | 30 days post lung transplantation |
|
|
|
|
| Other Pre-specified | Long-term Survival: Survival at 12-months Post-transplant | Survival outcomes were collected through one year post-transplant. | Posted | Count of Participants | Participants | 12-months |
|
|
|
| 7 |
| 79 |
| 61 |
| 79 |
| 67 |
| 79 |
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Immune system disorders | Immune system disorders | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Endocrine disorders | Endocrine disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
|
| Immune system disorders | Immune system disorders | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
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.