Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
NCT ID: NCT01365429
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
252 participants
INTERVENTIONAL
2011-05-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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EVLP Group
EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the XPS™ with Steen Solution™ and undergone ex-vivo lung perfusion before being transplanted.
XPS™ with Steen Solution™
The XPS™ System is an integrated cardiac bypass system comprised of various components such as a Maquet CardioHelp centrifugal pump (K102726), the HicoVariotherm Heater/Cooler, the Hamilton C2 ICU (intensive care unit) pressure- controlled ventilator (K092148), the perfusate gas monitors, and the display monitors. The XPS™ System is responsible for housing the organ for preservation, providing the normothermic environment, and perfusing the organ with the STEEN Solution™. Donor lungs that meet inclusion criteria are placed on the XPS™ and rewarmed and perfused with STEEN Solution™ and ventilated for 3-6 hours. If the lungs meet transplant suitability, they are cooled down and transplanted into a consented recipient that meet's trial criteria.
Control Group
Control Group are those recipient lung transplant patients that receive donor lungs via conventional transplant.
No interventions assigned to this group
Interventions
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XPS™ with Steen Solution™
The XPS™ System is an integrated cardiac bypass system comprised of various components such as a Maquet CardioHelp centrifugal pump (K102726), the HicoVariotherm Heater/Cooler, the Hamilton C2 ICU (intensive care unit) pressure- controlled ventilator (K092148), the perfusate gas monitors, and the display monitors. The XPS™ System is responsible for housing the organ for preservation, providing the normothermic environment, and perfusing the organ with the STEEN Solution™. Donor lungs that meet inclusion criteria are placed on the XPS™ and rewarmed and perfused with STEEN Solution™ and ventilated for 3-6 hours. If the lungs meet transplant suitability, they are cooled down and transplanted into a consented recipient that meet's trial criteria.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or Female, 18 years of age or older.
3. Subject or Subject's Representative provides a legally effective informed consent.
1. The Donor lung must meet the following criteria to proceed with EVLP:
2. At the time of the clinical evaluation , the PaO2/FiO2 ≤ 300mmHg Or If PaO2/FiO2 \> 30mmHg and the donor has any one or more of the following donor risk factors:
* Multiple blood transfusions.
* Pulmonary edema detected via CXR, bronchoscopy or palpation of lungs.
* Donation after circulatory death donors.
* Investigator evaluation of donor lung as "unsuitable" for standard criteria for lung transplant. List reason for "unsuitable" determination.
1. Surgeon must be clinically satisfied with the lung evaluation (i.e.) overall improvement, if not, the reason for refusal must be listed.
2. Stability or improvement of other lung function parameters during EVLP perfusion - PVR, Compliance, Airway Pressures.
3. Two delta PO2 greater than 350 mmHg, if two delta PO2 mm Hg are not met than three out of four of the following parameters must be present:
* One delta PO2 of \> 350 or absolute PO2 of \> 400.
* Chest x-ray findings with absence or improvement of pulmonary edema/infiltrates
* Compliance static (greater than 35 single and greater than 60 for a double)
* Absence of consolidation by palpation
Exclusion Criteria
2. A recipient has active Hepatitis.
3. Investigator believes that the recipient has infection that excludes them from transplant in the study.
4. To receive multi-organ transplant.
5. Is on hemodialysis or has chronic severe renal dysfunction. Severe renal dysfunction is defined as a glomerular filtration rate of 29 or less (mL/min/1.73m2).
6. Is to have planned concurrent cardiac procedures.
7. A recipient is a re-transplant. (A re-transplant is defined as a recipient having the removal and transplant of a previously transplanted lung. A recipient with a previously single lung transplant is eligible to enroll in the trial if it is for the other lung and within 6 months of previous transplant.)
8. A recipient is on Nova Lung, ECMO, or on mechanical ventilation. (CPAP and BIPAP are not exclusionary)
1. Lung has significant pneumonia and/or persistent purulent secretions on bronchoscopy as determined by investigator.
2. Donor has known significant aspiration of gastric contents within the lung.
3. Donor lung has significant mechanical lung injury or trauma determined by chest x-ray, bronchoscopy, CT Scan or visual inspection.
4. Donor lung has active infectious disease such as HIV, Hepatitis B or C, HTLV or Syphilis. Note: This information is not available at the start of EVLP. Therefore this criteria can be assessed during or post EVLP, but prior to transplant.
1. All delta PO2 (s) are less than 350 mmHg (measured with a FiO2 set at 1.0) or all absolute PO2s are less than 400.
2. Overall greater than 10-15% Functional deterioration of other lung function across all parameters (PVR, Compliance, PawP) with chest x-ray findings showing deterioration.
3. Donor lung positive for infectious diseases such as HIV, Hepatitis B or C, or Syphilis.
Note: This information is not available until at the start of EVLP. Therefore this criteria can be assessed during or post EVLP, but prior to transplant.
18 Years
ALL
No
Sponsors
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XVIVO Perfusion
INDUSTRY
Responsible Party
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Principal Investigators
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Jaya Tiwari, BS, CCRP
Role: STUDY_DIRECTOR
XVIVO Perfusion, Inc
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
University of Florida-Gainesville
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford
Detroit, Michigan, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Columbia University Medical Centre
New York, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8. doi: 10.1067/mtc.2002.120345.
Fisher AJ, Donnelly SC, Hirani N, Haslett C, Strieter RM, Dark JH, Corris PA. Elevated levels of interleukin-8 in donor lungs is associated with early graft failure after lung transplantation. Am J Respir Crit Care Med. 2001 Jan;163(1):259-65. doi: 10.1164/ajrccm.163.1.2005093.
Power BM, Van Heerden PV. The physiological changes associated with brain death--current concepts and implications for treatment of the brain dead organ donor. Anaesth Intensive Care. 1995 Feb;23(1):26-36. doi: 10.1177/0310057X9502300107.
Avlonitis VS, Wigfield CH, Golledge HD, Kirby JA, Dark JH. Early hemodynamic injury during donor brain death determines the severity of primary graft dysfunction after lung transplantation. Am J Transplant. 2007 Jan;7(1):83-90. doi: 10.1111/j.1600-6143.2006.01593.x.
Botha P, Fisher AJ, Dark JH. Marginal lung donors: A diminishing margin of safety? Transplantation. 2006 Nov 27;82(10):1273-9. doi: 10.1097/01.tp.0000236099.52382.74.
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Botha P, Trivedi D, Weir CJ, Searl CP, Corris PA, Dark JH, Schueler SV. Extended donor criteria in lung transplantation: impact on organ allocation. J Thorac Cardiovasc Surg. 2006 May;131(5):1154-60. doi: 10.1016/j.jtcvs.2005.12.037.
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Yamane M, Date H, Okazaki M, Toyooka S, Aoe M, Sano Y. Long-term improvement in pulmonary function after living donor lobar lung transplantation. J Heart Lung Transplant. 2007 Jul;26(7):687-92. doi: 10.1016/j.healun.2007.04.008. Epub 2007 Jun 13.
Steen S, Sjoberg T, Pierre L, Liao Q, Eriksson L, Algotsson L. Transplantation of lungs from a non-heart-beating donor. Lancet. 2001 Mar 17;357(9259):825-9. doi: 10.1016/S0140-6736(00)04195-7.
de Antonio DG, Marcos R, Laporta R, Mora G, Garcia-Gallo C, Gamez P, Cordoba M, Moradiellos J, Ussetti P, Carreno MC, Nunez JR, Calatayud J, Del Rio F, Varela A. Results of clinical lung transplant from uncontrolled non-heart-beating donors. J Heart Lung Transplant. 2007 May;26(5):529-34. doi: 10.1016/j.healun.2007.01.028.
Steen S, Liao Q, Wierup PN, Bolys R, Pierre L, Sjoberg T. Transplantation of lungs from non-heart-beating donors after functional assessment ex vivo. Ann Thorac Surg. 2003 Jul;76(1):244-52; discussion 252. doi: 10.1016/s0003-4975(03)00191-7.
Snell GI, Oto T, Levvey B, McEgan R, Mennan M, Higuchi T, Eriksson L, Williams TJ, Rosenfeldt F. Evaluation of techniques for lung transplantation following donation after cardiac death. Ann Thorac Surg. 2006 Jun;81(6):2014-9. doi: 10.1016/j.athoracsur.2006.01.014.
Cypel M, Sato M, Yildirim E, Karolak W, Chen F, Yeung J, Boasquevisque C, Leist V, Singer LG, Yasufuku K, Deperrot M, Waddell TK, Keshavjee S, Pierre A. Initial experience with lung donation after cardiocirculatory death in Canada. J Heart Lung Transplant. 2009 Aug;28(8):753-8. doi: 10.1016/j.healun.2009.05.009. Epub 2009 Jun 28.
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.
Orens JB, Boehler A, de Perrot M, Estenne M, Glanville AR, Keshavjee S, Kotloff R, Morton J, Studer SM, Van Raemdonck D, Waddel T, Snell GI; Pulmonary Council, International Society for Heart and Lung Transplantation. A review of lung transplant donor acceptability criteria. J Heart Lung Transplant. 2003 Nov;22(11):1183-200. doi: 10.1016/s1053-2498(03)00096-2. No abstract available.
Ware LB, Wang Y, Fang X, Warnock M, Sakuma T, Hall TS, Matthay M. Assessment of lungs rejected for transplantation and implications for donor selection. Lancet. 2002 Aug 24;360(9333):619-20. doi: 10.1016/s0140-6736(02)09774-x.
Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjoberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4. doi: 10.1016/j.athoracsur.2007.01.033.
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.
Rega FR, Jannis NC, Verleden GM, Lerut TE, Van Raemdonck DE. Long-term preservation with interim evaluation of lungs from a non-heart-beating donor after a warm ischemic interval of 90 minutes. Ann Surg. 2003 Dec;238(6):782-92; discussion 792-3. doi: 10.1097/01.sla.0000098625.24363.d9.
Rega FR, Wuyts WA, Vanaudenaerde BM, Jannis NC, Neyrinck AP, Verleden GM, Lerut TE, Van Raemdonck DE. Nebulized N-acetyl cysteine protects the pulmonary graft inside the non-heart-beating donor. J Heart Lung Transplant. 2005 Sep;24(9):1369-77. doi: 10.1016/j.healun.2004.10.013.
Erasmus ME, Fernhout MH, Elstrodt JM, Rakhorst G. Normothermic ex vivo lung perfusion of non-heart-beating donor lungs in pigs: from pretransplant function analysis towards a 6-h machine preservation. Transpl Int. 2006 Jul;19(7):589-93. doi: 10.1111/j.1432-2277.2006.00318.x.
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Other Identifiers
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VSS-NA-001, XVO-NA-002
Identifier Type: -
Identifier Source: org_study_id
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