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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1HL113115-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Vitrolife | INDUSTRY |
| XVIVO Perfusion |
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The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex-vivo lung perfusion (EVLP) with STEEN Solution™ | Experimental | The perfusion of the lungs will be performed using STEEN Solution™. The lungs will be physiologically assessed during ex vivo perfusion with STEEN Solution™ perfusate. |
|
| Lung transplant from conventional brain-dead organ donor | No Intervention | No experimental procedures will be carried out. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ | Procedure | After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™, and taken to UNCH where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNC Hospitals and Duke University Medical Center based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Mortality and Graft Survival | The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes. | 30 Days |
| Primary Lung Graft Dysfunction (PGD) | Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. Grade 0: PaO2/FIO2 > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200. | 24 and 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective. | Time to Discharge, up to 30 days |
| Day 7 Ventilator/ECMO Status |
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Inclusion Criteria:
Exclusion Criteria:
•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas M. Egan, MD, MSc. | UNC-Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16818116 | Background | Orens JB, Estenne M, Arcasoy S, Conte JV, Corris P, Egan JJ, Egan T, Keshavjee S, Knoop C, Kotloff R, Martinez FJ, Nathan S, Palmer S, Patterson A, Singer L, Snell G, Studer S, Vachiery JL, Glanville AR; Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. International guidelines for the selection of lung transplant candidates: 2006 update--a consensus report from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2006 Jul;25(7):745-55. doi: 10.1016/j.healun.2006.03.011. No abstract available. | |
| 19101308 |
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Lungs were recovered from 35 NHBDs, 22 had EVLP. Two lung blocks were judged suitable, but not transplanted: No consented recipient available for #1, protocol time specifications could not be met for #2. As such, no subjects enrolled into EVLP arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ex-vivo Lung Perfusion With STEEN Solution™ | Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan. |
| FG001 | Lung Transplant From Conventional Brain-dead Organ Donor |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| INDUSTRY |
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|
| STEEN Solution™ | Device | This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs. |
|
Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.
| 7 Days Post Transplant. |
| Recipient Mortality at 12 Months | Recipient mortality at 12 months post transplant is being evaluated as a secondary objective. | 12 months |
| Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival | Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome. | 12 Months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Background |
| Ingemansson R, Eyjolfsson A, Mared L, Pierre L, Algotsson L, Ekmehag B, Gustafsson R, Johnsson P, Koul B, Lindstedt S, Luhrs C, Sjoberg T, Steen S. Clinical transplantation of initially rejected donor lungs after reconditioning ex vivo. Ann Thorac Surg. 2009 Jan;87(1):255-60. doi: 10.1016/j.athoracsur.2008.09.049. |
| 18954650 | Background | Mason DP, Thuita L, Alster JM, Murthy SC, Budev MM, Mehta AC, Pettersson GB, Blackstone EH. Should lung transplantation be performed using donation after cardiac death? The United States experience. J Thorac Cardiovasc Surg. 2008 Oct;136(4):1061-6. doi: 10.1016/j.jtcvs.2008.04.023. |
| 19059112 | Background | Cypel M, Yeung JC, Hirayama S, Rubacha M, Fischer S, Anraku M, Sato M, Harwood S, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Technique for prolonged normothermic ex vivo lung perfusion. J Heart Lung Transplant. 2008 Dec;27(12):1319-25. doi: 10.1016/j.healun.2008.09.003. |
| 16564244 | Background | Egan TM, Haithcock JA, Nicotra WA, Koukoulis G, Inokawa H, Sevala M, Molina PL, Funkhouser WK, Mattice BJ. Ex vivo evaluation of human lungs for transplant suitability. Ann Thorac Surg. 2006 Apr;81(4):1205-13. doi: 10.1016/j.athoracsur.2005.09.034. |
| 16210116 | Background | Christie JD, Carby M, Bag R, Corris P, Hertz M, Weill D; ISHLT Working Group on Primary Lung Graft Dysfunction. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction part II: definition. A consensus statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2005 Oct;24(10):1454-9. doi: 10.1016/j.healun.2004.11.049. Epub 2005 Jun 4. No abstract available. |
| 18852649 | Background | Kim IK, Bedi DS, Denecke C, Ge X, Tullius SG. Impact of innate and adaptive immunity on rejection and tolerance. Transplantation. 2008 Oct 15;86(7):889-94. doi: 10.1097/TP.0b013e318186ac4a. |
| 19118301 | Background | Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289. |
| 20368171 | Background | Cypel M, Liu M, Rubacha M, Yeung JC, Hirayama S, Anraku M, Sato M, Medin J, Davidson BL, de Perrot M, Waddell TK, Slutsky AS, Keshavjee S. Functional repair of human donor lungs by IL-10 gene therapy. Sci Transl Med. 2009 Oct 28;1(4):4ra9. doi: 10.1126/scitranslmed.3000266. |
| 21488765 | Background | Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597. |
| 28945476 | Derived | Egan T, Blackwell J, Birchard K, Haithcock B, Long J, Gazda S, Casey N, Thys C. Assessment of Lungs for Transplant Recovered from Uncontrolled Donation after Circulatory Determination of Death Donors. Ann Am Thorac Soc. 2017 Sep;14(Supplement_3):S251. doi: 10.1513/AnnalsATS.201609-687MG. |
No experimental procedures will be carried out. |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ex-vivo Lung Perfusion With STEEN Solution™ | Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan. |
| BG001 | Lung Transplant From Conventional Brain-dead Organ Donor | No experimental procedures will be carried out. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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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 | 30 Day Mortality and Graft Survival | The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes. | Posted | Count of Participants | Participants | 30 Days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Primary Lung Graft Dysfunction (PGD) | Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. Grade 0: PaO2/FIO2 > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200. | Posted | Count of Participants | Participants | 24 and 72 hours |
|
| |||||||||||||||||||||||||||||||||
| Secondary | ICU Length of Stay | The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective. | Posted | Mean | Standard Deviation | Days | Time to Discharge, up to 30 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Day 7 Ventilator/ECMO Status | Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated. | Posted | Count of Participants | Participants | 7 Days Post Transplant. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Recipient Mortality at 12 Months | Recipient mortality at 12 months post transplant is being evaluated as a secondary objective. | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival | Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome. | Excludes those who were deceased at Month 12 | Posted | Count of Participants | Participants | 12 Months |
|
|
From the date of transplant through 12 months post-op
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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 | Ex-vivo Lung Perfusion With STEEN Solution™ | Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™ and CT scan. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Lung Transplant From Conventional Brain-dead Organ Donor | No experimental procedures will be carried out. | 5 | 24 | 0 | 24 | 16 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and/or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acute Rejection | Immune system disorders | Non-systematic Assessment |
| ||
| Pyrexia | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cytomegalovirus (CMV) | Infections and infestations | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
| ||
| Empyema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Lungs recovered from 35 NHBDs, 22 had EVLP. Two lung blocks judged suitable, but not transplanted: no consented recipient available for #1, protocol time specifications could not be met for #2. As such, no subjects enrolled into EVLP arm.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Egan, MD, MSc, FACS | University of North Carolina at Chapel Hill | 919-966-3381 | thomas_egan@med.unc.edu |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003550 | Cystic Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D001987 | Bronchiectasis |
| D012507 | Sarcoidosis |
| D006976 | Hypertension, Pulmonary |
| D019896 | alpha 1-Antitrypsin Deficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
| D001982 | Bronchial Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008107 | Liver Diseases |
| D013352 | Subcutaneous Emphysema |
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| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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