Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability

Tracking Information
First Submitted Date ICMJE	November 12, 2010
First Posted Date ICMJE	November 16, 2010
Last Update Posted Date	February 6, 2017
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 15, 2010)	30 Day Mortality [ Time Frame: 30 Days ]; The primary objective evaluated for this study is recipient mortality at 30 days post transplant. 30 day mortality is used as a standard research assessment to evaluate post transplant outcomes.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01241942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 15, 2010)	Primary Lung Graft Dysfunction (PGD) [ Time Frame: 24 and 72 hours post transplant. ]Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation. PGD at 24 and 72 hours post LTX are secondary objectives.; ICU Length of Stay [ Time Frame: Time to Discharge. ]The length of ICU stay is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.; Day 7 Ventilator/ECMO Status [ Time Frame: 7 Days Post Transplant. ]7 days ventilator or extra-corporeal membrane oxygenator (ECMO free are being evaluated as secondary objectives.; Recipient mortality at 12 months. [ Time Frame: 12 months ]Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
Official Title ICMJE	Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability
Brief Summary	The purpose of this research study is to perfect the technique of EVLP and learn about the safety of transplanting lungs 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 lung perfusion and ventilation (EVLP) is to learn how well the lungs work, and whether they are likely safe to transplant.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility
Condition ICMJE	Emphysema; Chronic Obstructive Pulmonary Disease (COPD); Cystic Fibrosis; Pulmonary Fibrosis; Bronchiectasis; Sarcoidosis; Pulmonary Hypertension; Alpha-1 Antitrypsin Deficiency
Intervention ICMJE	Device: Steen Solution™ 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. 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 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 with Steen Solution™ will be transplanted into recipients as per current clinical practice.; Other: Conventional Lung Transplant No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
Study Arms	Experimental: EVLP with STEEN Solution™ The perfusion of the lungs will be performed using STEEN Solution™ and then physiologically assessed. Lungs deemed suitable will be transplanted after Ex-vivo Perfusion w/ STEEN Solution™. Intervention: Device: Steen Solution™; Active Comparator: Conventional Lung transplant No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant. Intervention: Other: Conventional Lung Transplant
Publications *	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.; Ingemansson R, Eyjolfsson A, Mared L, Pierre L, Algotsson L, Ekmehag B, Gustafsson R, Johnsson P, Koul B, Lindstedt S, Lührs C, Sjöberg 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.; 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.; 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.; 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.; 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. Epub 2005 Jun 4.; 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. Review.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: July 8, 2016)	103
Original Estimated Enrollment ICMJE; (submitted: November 15, 2010)	20
Actual Study Completion Date	June 2013
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Lung Recipient Inclusion Criteria: A recipient must meet the following requirement to enroll into the study:; Requires a single or bilateral lung transplant and is listed for lung transplant at UNC.; Male or Female, 18 years of age or older.; Subject or Subject's Representative provides a legally effective informed consent.; Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.; Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria are eligible for study participation. Lung Recipient Exclusion Criteria: Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01241942
Other Study ID Numbers ICMJE	UNC-001 Vitrolife
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: Yes Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	University of North Carolina, Chapel Hill
Study Sponsor ICMJE	University of North Carolina, Chapel Hill
Collaborators ICMJE	Vitrolife; XVIVO Perfusion
Investigators ICMJE	Principal Investigator: Thomas M. Egan, MD, MSc. UNC-Chapel Hill
PRS Account	University of North Carolina, Chapel Hill
Verification Date	July 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP