Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs

NCT01365429 | Unknown DMC

• 1 other identifier: VSS-NA-001, XVO-NA-002
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 18

Brief Summary

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.

Conditions

Lung Transplant

Keywords

Lung Transplant, Transplantation Lung

Outcome Measures

Primary Outcomes (2)

• PAS Study Primary Endpoint

  The primary end point is a co-primary endpoint comparing survival rates and rates of grade 3 PGD at 72 hours with success if and only if both endpoints are met. Treatment Group (T) = EVLP transplant subjects Control Group (C) = standard transplant subjects Co-Primary Endpoints: Endpoint #1: Survival of T is non-inferior to C Ho: C - T ≥ M1 (T is inferior to the control by M1 or more) Ha: C - T \< M1 (T is inferior to the control by less than M1) where M1 = 0.12 Endpoint #2: Rate of grade 3 PGD at 72 hours for T is non-inferior to the rate for C Ho: C - T ≥ M2 Ha: C - T \< M2 where M2 = 0.12

  3 Years

• PMA Study Primary Endpoint

  The primary end point is non-inferiority of the 3-year survival rate of the EVLP group as compared to 3-year survival rate of the control group. Ho: C - T ≥ M3 (T is inferior to the control by M3 or more) Ha: C - T \< M3 (T is inferior to the control by less than M3) where M3 = 0.12

  72hrs and Survival

Secondary Outcomes (2)

• PMA Secondary Endpoints

  3 Years

• PAS Secondary Endpoint:

  5 Years

Study Arms (2)

EVLP Group

EXPERIMENTAL

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.

Device: XPS™ with Steen Solution™

Control Group

NO INTERVENTION

Control Group are those recipient lung transplant patients that receive donor lungs via conventional transplant.

Interventions

XPS™ with Steen Solution™ DEVICE

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.

Also known as: EVLP, ex vivo lung perfusion

EVLP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Requires single or bilateral lung transplant.
• Male or Female, 18 years of age or older.
• Subject or Subject's Representative provides a legally effective informed consent.
• A recipient is HIV positive.
• A recipient has active Hepatitis.
• Investigator believes that the recipient has infection that excludes them from transplant in the study.
• To receive multi-organ transplant.
• 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).
• Is to have planned concurrent cardiac procedures.
• 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.)
• The Donor lung must meet the following criteria to proceed with EVLP:
• 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.

Sponsors & Collaborators

• XVIVO Perfusion: lead

Study Sites (18)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida-Gainesville

Gainesville, Florida, 32610, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Chicago

Chicago, Illinois, 60631, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Centre

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15632, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (29)

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  PMID: 17449425 BACKGROUND

• 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.

  PMID: 12842550 BACKGROUND

• 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.

  PMID: 16731122 BACKGROUND

• 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.

  PMID: 19632569 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Interventions

Photoelectron Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jaya Tiwari, BS, CCRP

  XVIVO Perfusion, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

US (18)