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A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Lung (Treatment Group) | Experimental | The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. |
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| Cold flush and storage (Control Group) | Active Comparator | Donor lungs will be preserved using cold flush and storage (control group) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Lung | Device | OCS Lung will be used to preserve the donor lungs (Treatment Group). |
|
| Measure | Description | Time Frame |
|---|---|---|
| A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation. | This composite is a single outcome measure. 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. | Day 30 after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-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 after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject | 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-transplant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbas Ardehali, MD | Ronald Reagan Medical Center, UCLA | Study Director |
| Dirk van Raemodonck, MD | UZ Leuven, Belgium | Study Director |
| Gregor Warnecke, MD | Hannover Medical Center, Germany | Study Director |
| 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 |
|---|---|---|---|
| 29650408 | Derived | Warnecke G, Van Raemdonck D, Smith MA, Massard G, Kukreja J, Rea F, Loor G, De Robertis F, Nagendran J, Dhital KK, Moradiellos Diez FJ, Knosalla C, Bermudez CA, Tsui S, McCurry K, Wang IW, Deuse T, Leseche G, Thomas P, Tudorache I, Kuhn C, Avsar M, Wiegmann B, Sommer W, Neyrinck A, Schiavon M, Calabrese F, Santelmo N, Olland A, Falcoz PE, Simon AR, Varela A, Madsen JC, Hertz M, Haverich A, Ardehali A. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9. | |
| 25284600 |
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| ID | Title | Description |
|---|---|---|
| FG000 | OCS Lung (Treatment Group) | The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group). |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Cold flush and storage | Device | Donor lungs will preserved using standard cold flush and storage |
|
|
| Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-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 after transplantation |
| Patient Survival at Day 30 | Day 30 |
| Long-term Survival: 24-month Survival | 24 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| St. Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Hospitals Leuven | Leuven | 3000 | Belgium |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| University Hospitals of Marseille | Marseille | 13915 | France |
| Groupe Hospitalier Hopitaux Universitaries | Paris | 18 eme | France |
| N.H.C Hospital Civil | Strasbourg | 67091 | France |
| German Heart Institute Berlin | Berlin | D-13353 | Germany |
| Universitäres Herzzentrum Hamburg GmbH | Hamburg | 20246 | Germany |
| Hannover Medical School | Hanover | D-300625 | Germany |
| University of Padua | Padua | 35128 | Italy |
| University Puerta de Hierro Hospital | Madrid | 28222 | Spain |
| Papworth Hospital | Cambridge | CB23 3 RE | United Kingdom |
| Harefield Hospital | Middlesex | UB9 6JH | United Kingdom |
| Derived |
| Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27. No abstract available. |
| FG001 |
| Cold Flush and Storage (Control Group) |
Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
|
| Safety Population |
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| Per Protocol Population |
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| COMPLETED | Number of per protocol subjects that completed 24-month follow-up |
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| NOT COMPLETED |
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Intent-to-treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | OCS Lung (Treatment Group) | The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group). |
| BG001 | Cold Flush and Storage (Control Group) | Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Donor Age (years) | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Continuous | Recipient Age (years) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Donor Sex (Male/Female) | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Recipient Sex (Male/Female) | Count of Participants | Participants |
| |||||||||||||||
| Donor Smoking History in Past 6 Months | Count of Participants | Participants |
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| Final PaO2:FiO2 (mm Hg) | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| Recipient Transplant Indication | Count of Participants | Participants |
| ||||||||||||||||
| 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. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Recipient BMI | Mean | Standard Deviation | kg/m^2 |
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| 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 | A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation. | This composite is a single outcome measure. 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 | Day 30 after transplantation |
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| Secondary | Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-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. | Posted | Count of Participants | Participants | 72 hours after transplantation |
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| Secondary | Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-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. | Posted | Count of Participants | Participants | 72 hours after transplantation |
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| Secondary | Patient Survival at Day 30 | Posted | Count of Participants | Participants | Day 30 |
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| Other Pre-specified | Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject | 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. | This analysis was done on the safety population. | Posted | Mean | 95% Confidence Interval | events per participant | 30 days post-transplant |
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| Other Pre-specified | Long-term Survival: 24-month Survival | Posted | Count of Participants | Participants | 24 months |
|
Adverse events were collected for 30 days post-transplant or through hospital discharge if longer than 30 days. All-cause mortality is reported through 24-months post transplant.
The primary safety endpoint was lung graft-related serious adverse events within 30 days (acute rejection, respiratory failure, bronchial anastomotic complications, and major pulmonary-related infection).
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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 | OCS Lung (Treatment Group) | The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group). | 24 | 151 | 83 | 150 | 125 | 150 |
| EG001 | Cold Flush and Storage (Control Group) | Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage | 27 | 169 | 107 | 169 | 141 | 169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
| ||
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| Immune system disorders | Immune system disorders | Systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
| ||
| General disorders and administration site conditions | General disorders | Systematic Assessment |
| ||
| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
| ||
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
| ||
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Investigations | Investigations | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| Immune system disorders | Immune system disorders | Systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
| ||
| General disorders and administration site conditions | General disorders | Systematic Assessment |
| ||
| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
| ||
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
| ||
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Investigations | Investigations | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Endocrine disorders | Endocrine disorders | Systematic Assessment |
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| Eye disorders | Eye disorders | Systematic Assessment |
| ||
| Ear and labyrinth disorders | Ear and labyrinth disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Affairs | TransMedics, Inc. | 978.552.0900 | ldamme@transmedics.com |
| Male |
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| Male |
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| Pulmonary Fibrosis |
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| Cystic Fibrosis |
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| Idiopathic Pulmonary Hypertension |
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| Sarcoidosis |
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| Other |
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| 0.06 |
| difference of proportion |
| -0.038 |
| 1-Sided |
| 95 |
| 0.045 |
| Non-Inferiority |
The non-inferiority margin, which is here taken to be 0.04. |
| OG003 | Cold Flush and Storage (Control Group) - ITT | Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
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| OG003 | Cold Flush and Storage (Control Group) - ITT | Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
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Donor lungs will be preserved using cold flush and storage (control group)
Cold flush and storage: Donor lungs will preserved using standard cold flush and storage
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Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
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